Christopher Cole

CNPV Deep Dive | Image created with Canva.

 with five bio/pharmaceutical industry experts to analyze the implications of the FDA Commissioner’s National Priority Voucher (CNPV) pilot program (1). At the same time, our colleagues at 

 spoke with expert advisors and subject matter experts in academia to understand their perspectives on the CNPV. The program has garnered significant attention because it offers an "unprecedented opportunity to reduce drug and biological product application or efficacy supplement review times from 10-12 months to just 1-2 months" (2,3). FDA Commissioner Marty Makary, MD, MPH, characterized CNPV as a “common-sense approach” designed to harness a "tumor board style" discussion to deliver "more cures and meaningful treatments to the American public” (3). However, this accelerated pathway comes with a warning from experts in public health and regulatory policy that this speed may come at the expense of established safety standards and fiscal responsibility (1,4-6). The pilot is proving to be far more than just a speed boost; it is reshaping how sponsors approach manufacturing, market access, and their relationship with the regulator.



Speed to Market | Created with NotebookLM.

How must sponsors fundamentally shift their operational playbook to meet compressed timelines?

The dramatic compression of the review window necessitates a complete overhaul of a sponsor’s traditional drug development and submission playbook. The reduction in formal review time does not mean that product development, marketing preparation, or post-approval planning must also be compressed proportionally. Instead, sponsors must execute market access, pricing, and post-approval readiness activities in parallel with development.

John Kirk, principal regulatory strategist at Veristat, 

underscores the essential pre-submission timeline

, noting that "To use a voucher for the short review period, sponsors must submit the CMC section of the marketing application at least 60 days before submitting the complete application." This mandate fundamentally changes the required speed of internal operations, meaning that manufacturing must be "commercially ready sooner than necessary for a standard NDA." Kirk adds that clinical trials needed for the marketing application must be "completed on time and be of high quality to facilitate review and pre-approval inspections."

Metin Çelik, PhD, president of Pharmaceutical Technologies International, Inc (PTI), 

details the strategic implications for commercialization

: "Market access strategy, pricing scenarios, health economics and outcomes research models, and payer engagement must begin during late-phase clinical development—not after filing." Furthermore, Çelik asserts that "Manufacturing and supply chain readiness (tech transfer, process performance qualification, control strategy, domestic/dual sourcing, quality system robustness) must be essentially complete at submission." To manage this, teams need to operate through integrated readiness “war rooms” with weekly cross-functional reviews across various disciplines.

Aloka Srinivasan, principal and managing partner at Raaha LLC, 

confirms that for generics and biosimilars receiving a voucher

, "What is most important... is careful planning." The new paradigm is defined by the fact that reviews "will occur on a rolling basis with increased interaction between the sponsor and the review team." This support requires a "shift in mindset" for sponsors, who must treat these pre-submission interactions as “information requests” or "discipline-specific" inquiries they are used to getting after the submission of the dossier. Ultimately, the intense pre-submission preparation ensures the final filing will resemble a “first-cycle approval,” in which the "Agency works closely with the sponsor to resolve all issues well before the actual submission is filed".

Is the CNPV program effectively achieving its goal of incentivizing domestic manufacturing?

A major, politically critical objective of the CNPV program is to strengthen the domestic supply chain (1). The program explicitly aims to "incentivize domestic manufacturing of certain critical drugs without cutting corners related to product development or quality," notes Srinivasan. Henrik Johanning, senior vice president of Quality & Strategy at Epista Life Science, confirms that "on-shoring is one of the explicit selection criteria." FDA uses the program to steer advanced manufacturing, especially sterile injectables and biologics, back to the US to "rebuild domestic pharmaceutical capacity after decades of off-shoring to Asia and Eastern Europe" and "strengthen supply-chain resilience," Johanning explains. This domestic focus is considered a prerequisite for accelerated review. Johanning adds that the program also aims to "safeguard, protect, and ‘grow’ critical manufacturing know-how in areas such as biologics, cell therapies, and advanced aseptic systems."

However, the initial CNPV awards suggest that while domestic manufacturing is a priority, it may not be the primary driver of selection. Brad Stewart, National life sciences co leader at BDO, 

 as "sort of an evolving opportunity for people." Stewart notes that while onshoring is a stated priority, "out of the vouchers that have been issued, most of them have not been for that reason." In fact, Stewart observes that "There's only been two that were specifically for manufacturing."

Thani Jambulingam, PhD, Professor at Saint Joseph's University, 

confirms that the first two cohorts of CNPV recipients

 "are not a random mix of assets." Jambulingam concludes that the winners "weren’t just those with breakthrough science, but those with operational models ready for an accelerated, politically salient, affordability-linked regulatory environment." The awards "reveal a clear bias in favor of companies that were operationally ready to move fast, willing to make explicit affordability and onshoring commitments, and already deeply engaged with the FDA."

How do affordability requirements impact FDA's traditional regulatory role?

The CNPV program introduces an affordability component that complicates traditional regulatory boundaries, particularly concerning cost evaluation. Ed Schoonveld, Value and access advisor at Schoonveld Advisory, 

explains that affordability is not strictly defined as price cutting

, but can also involve "offsetting medical treatments’ total healthcare costs." Schoonveld emphasizes that there are "plenty of opportunities to find other offsets without just focusing on price cutting."

Schoonveld expresses concern about the FDA's potential role in cost evaluation: "What's concerning me a little bit is that it seems that FDA is encroaching in the price-setting cost evaluation domain." While he notes that the CNPV program may not be severely damaging immediately, it could be seen as potentially "a step for the FDA toward getting into that field." Furthermore, Schoonveld questions the logic of accelerated launch tied solely to pricing, arguing that for a company to develop a drug and then "create a quick launch because of a price cut doesn't intuitively make a lot of sense."

Ryan Conrad, visiting fellow at the Center on Health Policy at the Brookings Institution, 

provides context on the products receiving vouchers

, observing that "a lot of the drugs awarded CNPV vouchers were already-approved drugs for new indications." Conrad notes that this expansion of indications "is helpful on the payer side as it allows them to cover the drugs for a wider range of treatments."

Can FDA manage the logistical and risk implications of a rapid review?

The demand for speed inherently elevates risk, shifting it downstream in the development process. Johanning cautions that "from a risk and compliance perspective, compressed timelines amplify every weakness in a company’s quality risk management framework." With "less time for iterative review and data verification, risks can easily migrate downstream, into supply chain, labeling, or post-market surveillance."

Çelik explains that compressed reviews increase reliance on post-market commitments, including safety studies or risk evaluation and mitigation strategy adjustments, "because uncertainties cannot be resolved during the short review." To mitigate this, companies must prepare post-approval study proposals in advance, "invest early in CMC strength and supply chain resilience," and use digital tools and structured inspection-readiness systems to "anticipate and close gaps before filing." Çelik stresses that proactive preparation is mission critical because "with a potential 30–60-day review, there is no time to fix compliance gaps once the file is submitted."

Regarding logistical feasibility, Rory Budihandojo, independent good manufacturing practices consultant, 

: "It is not clear logistically how the FDA can provide resources needed for this short/intense review without impacting other FDA review programs." Budihandojo raises concerns that this could divert resources from the standard review program or even other priority review programs, such as the Priority Review Voucher, which expedites review to six months. Ryan Conrad notes that "workload is always an issue and if these reviews are taking up a lot of time and effort from other reviews, that’s not a good thing".

Johanning clarifies that the four-to-eight-week target is conditional, stressing it is only possible "if the dossier is complete and clean," and "the 4-8-week target assumes pre-submission review and flawless CMC." Johanning also confirms that if a sponsor manufactures a product under this program and wants to sell their approval, they cannot, as the vouchers "are non-transferable" and "tied to the specific product and sponsor." However, despite the operational and logistical hurdles, Johanning believes the CNPV is a serious endeavor, calling it "a very focused pilot, not a bureaucracy trap nor window dressing." Sponsors who do not receive a voucher still "retain full access to the well-established expedited pathways (Fast Track, Breakthrough, Priority Review, Accelerated Approval)."

How is CNPV pilot program timing already changing?

Since the above discussions occurred, Augmentin XR, an amoxicillin-clavulanate potassium antibiotic made by USAntibiotics, became the

, with FDA saying the approval was completed in just two months (7). Antibiotics, particularly amoxicillin, have been subject to increasing, documented shortages in the past two decades, according to FDA.

"Over the past few decades, America lost control of supply chains for key medicines we depend on,” FDA Commissioner Marty Makary, MD, MPH, said in a press release (7). “That chapter is over—we’re entering a new era of manufacturing here at home. This first drug approval under the CNPV pilot program will strengthen domestic manufacturing and increase our national security."

Then, just one day after phase III trial results were released, Johnson & Johnson’s Tecvayli (teclistamab-cqyv), used in combination with daratumumab to treat relapsed or refractory multiple myeloma,  

received FDA’s latest national priority voucher

, becoming the 16th therapy chosen under the CNPV pilot program. “Within hours of the trial results being published in the American Society of Hematology conference program, FDA leaders read the study, consulted with internal experts, and the following day contacted the company to discuss a national priority voucher," said Makary in a press release. "When a treatment demonstrates outstanding trial results, we have a duty to patients to move swiftly”(8). 

The move to award a voucher so quickly suggests the CNPV pilot program timing is dynamic, yet another twist in an era requiring pharmaceutical developers and manufacturers to adapt and pivot on the fly. We at 

 will certainly keep a close eye on CNPV developments, so be sure to check back often. 

Commissioner's National Priority Voucher (CNPV) Pilot Program

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First Approval in Commissioner's National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity.

 Press Release. Last updated Dec. 10, 2025.

FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study Results

Articles

The FDA's National Priority Voucher (CNPV) pilot program aims to drastically reduce drug review times, offering a significant opportunity for faster market access. However, this acceleration raises concerns about maintaining safety standards and fiscal responsibility. Sponsors must adapt their operational strategies to meet compressed timelines, focusing on parallel execution of market access and post-approval activities. The program also seeks to incentivize domestic manufacturing, though initial awards suggest other factors may drive selection. Additionally, the program introduces affordability considerations, potentially complicating the FDA's traditional regulatory role and increasing logistical challenges.

Industry experts talk with PharmTech, Pharmaceutical Commerce, Applied Clinical Trials, and Pharmaceutical Executive about FDA's CNPV pilot program.

CNPV Deep Dive: Perspectives on Accelerated FDA Review From the C-Suite to the Manufacturing Floor

What should pharma industry professionals know about outsourcing?

Pharma teams should recognize that outsourcing can deliver cost efficiencies, scalability, and specialized expertise, but it also brings risks—including regulatory compliance gaps, data-security issues, and unforeseen expenses. Success requires careful planning, rigorous vendor evaluation, well-structured contracts, clear communication, continuous oversight, and full alignment of the partner with the company’s quality system (1-5).

What is the outlook for pharmaceutical outsourcing?

Contract service providers are currently challenged to 

 in an increasingly complex bio/pharma market. As molecular complexity increases, there is a growing need for 

How are relationships between sponsors and outsourcing partners evolving?

Customizable relationships are enhancing speed to market

. Sponsor companies and CDMOs (Contract Development and Manufacturing Organizations) are starting to view each other not merely as transactional relationships, but as 

What is the role of a CDMO in the supply chain?

, as discussed at CPHI Americas 2025. Key focus areas include the 

What recent collaborations or partnerships have been announced?

• A worldwide, exclusive license was granted for the development and commercialization of enzyme replacement therapies using proprietary platform technology as part of a 

 focused on BBB-crossing tech for lysosomal storage disorders.

alliance for radiopharmaceuticals was created by Medicines Discovery Catapult and Crown Bioscience

, collaborating on an integrated translational biology platform. This effort also included 

collaboration on the development of radiopharmaceuticals

MilliporeSigma and Simtra launched a five-year agreement

 for drug substance and drug manufacturing services, designed to offer a turnkey service to companies seeking faster time to market.

ten23 health joined Gerresheimer, SCHOTT, and Stevanato Group

 in the “Alliance for RTU” (Ready-to-Use), formed in response to increasing demand for aseptic filling technologies and processes.

AstraZeneca partnered with CSPC Pharmaceuticals on AI-enabled research

 to identify pre-clinical candidates for high-priority targets, including a small molecule oral therapy for immunological diseases.

What recent investments and expansions have outsourcing providers undertaken?

Several companies have announced major expansions or acquisitions in their manufacturing and services:

Bora Pharmaceuticals is expanding its Midwest manufacturing site

 in Maple Grove, Minnesota, focusing on manufacturing and packaging capabilities, following its 2024 acquisition of Upsher-Smith Laboratories. Bora also made 

 at their $80 million Kentucky facility, part of a $90 million investment plan.

• SK pharmteco is strengthening the domestic API supply chain with a 

 to its Latina, Italy site, expanding supply chain solutions for biologics and temperature-sensitive pharmaceuticals.

, which expands the CDMO’s small-molecule API development and manufacturing services in the US.

expanded its laboratory capacity and services

 at its German facility in Wiesbaden to respond to growing demand for packaging and microbiological testing.

expanding its CDMO offerings and showcasing packaging innovations

How are tariffs and trade policy impacting the bio/pharmaceutical outsourcing industry?

 indicate that the bio/pharma sector faces tariff-driven rising costs and supply strain. Firms are aiming to boost compliance and diversification while seeking stable trade and R&D support.

The Five-Step Guide to Effective Pharma Manufacturing Outsourcing

. Accessed Nov 25, 2025.
2. GForce Life Sciences. 

5 Big Challenges of Outsourcing in Pharma (And How to Avoid Them)

Building Strong Partnerships: Effective Outsourcing in the Pharmaceutical Sector

. Accessed Nov 25, 2025.
4. G.C. Chemie Pharmie Ltd. 

Why Outsource Manufacturing? Top 5 Advantages for Pharma & Supplements

. Accessed Nov 25, 2025.
5. Manufacturing Chemist. 

Outsourcing in Pharma: A Comprehensive Guide to strategic Advantages and Considerations

Outsourcing in the pharmaceutical industry offers cost efficiencies, scalability, and specialized expertise, but also presents risks such as regulatory compliance gaps and data-security issues. Success hinges on careful planning, vendor evaluation, and continuous oversight. The evolving role of CDMOs is crucial, with a focus on API quality and trusted relationships. Recent collaborations highlight advancements in enzyme replacement therapies, radiopharmaceuticals, and AI-enabled research. Investments in manufacturing expansions and acquisitions are notable, while tariffs and trade policies impact costs and supply chains, prompting firms to enhance compliance and diversification.

With big moves and investments being made via pharma outsourcing, it’s important for industry professionals to stay on top of trends and innovations.

FAQ: Pharmaceutical Outsourcing Trends and Innovations

speech bubbles concept 3d illustration | Image Credit: © frender - stock.adobe.com - modified in Canva by Chris Cole, PharmTech.

Editor’s Note: Opinions expressed herein do not necessarily reflect those of the firms/companies for which the speakers work.

additional coverage and industry expert perspectives in "

The Regulatory Crucible: Risk, Resource Drain, and the Hidden Trade-Offs of the CNPV Pilot Program

Ready or Not: Biopharma Alignment for CNPV’s Rapid Review

How the FDA Commissioner’s National Priority Vouchers Reshape Manufacturing, Pricing & Global Strategy

Winners & Losers: What the First FDA Commissioner’s National Priority Vouchers Tell Us About Early Movers vs. Late Movers"

from our colleagues over at Pharmaceutical Executive.

 held a discussion with six bio/pharmaceutical industry experts to better understand the impacts—both known and potential—of the FDA Commissioner’s National Priority Voucher (CNPV) pilot program (1). The program offers an "unprecedented opportunity to reduce drug and biological product application or efficacy supplement review times from 10-12 months to just 1-2 months" (2,3). While FDA Commissioner Marty Makary, MD, MPH, called CNPV a “common-sense approach” that harnesses a "tumor board style" discussion to deliver "more cures and meaningful treatments to the American public” (3), experts in public health and regulatory policy (1,4-6), warn that this acceleration may come at the expense of established safety standards and fiscal responsibility. Following is a recap of the second half of the discussion, moderated by Eric Langer, president and managing partner, BioPlan Associates.

Langer: Is CNPV a gimmick that will get bogged down in process complexity

Aloka Srinivasan, principal and managing partner at Raaha LLC:

 Priority vouchers have been issued by FDA for a long time, mostly for rare pediatric diseases. This is just an extension of the process. FDA has a process in place that they can now expand to include on-shored drugs with unmet needs. I feel innovator companies that have submitted new chemical entities to [various regulatory agencies] will be able to navigate this process. However, the generic companies, who are usually not used to communicating with the Agency to the extent that new drug sponsors do, will now need to change their mindset and be ready to do so. They will also need to understand the significance of rolling submissions, which means that the product and process development work and the review go on parallelly. It is definitely not a gimmick, but the process may feel complex to sponsors who are not used to working under this paradigm. Again, like priority reviews, we will know if this is beneficial only when the process is initiated by submission of a few dossiers for the selected products.

Henrik Johanning, senior vice president, Quality & Strategy, Epista Life Science: 

No. It’s a very focused pilot, not a bureaucracy trap nor window dressing. FDA has built a dedicated, cross-functional “rapid review” team and front-loads CMC and labeling work to exactly avoid hand-offs. It’s speed for ready programs, not a shortcut around quality.

Langer: Where’s the on-shoring benefit?

 The on-shoring benefit is especially high for generics and biosimilars. They will now get significant opportunities to communicate with FDA prior to their submissions. In case of generics that are non-complex, this is a rare luxury, as sponsors of such products have very few ways of communicating with the Agency prior to submission. The Generic Drug User Fee Amendments (7) allows controlled correspondences, which are cumbersome and time consuming, and sometime FDA responses generate more questions and answers. Most of the communications for generics happen post-submission, through information requests, discipline review letters, and sometimes complete response letters… Based on the voucher, the sponsor will get numerous opportunities to discuss the product and process with the Agency prior to submission of the dossier, and the expectation is that by the time they submit the dossier, hopefully most of the issues have been resolved.

On-shoring is one of the explicit selection criteria. FDA uses the program to steer advanced manufacturing, especially sterile injectables and biologics, back to the US. This is to strengthen supply-chain resilience, but also to rebuild domestic pharmaceutical capacity after decades of off-shoring to Asia and Eastern Europe. The program aims to:

Reduce strategic dependency on single-region, non-US suppliers for APIs and sterile products.

Safeguard, protect, and “grow" critical manufacturing know-how in areas such as biologics, cell therapies, and advanced aseptic systems.

Encourage modernization, using US-based continuous-manufacturing or single-use technologies.

Enhance regulatory agility, as US-based facilities are easier for FDA to inspect, monitor, and support during scale-up or remediation.

Drive economic return, supporting domestic biomanufacturing jobs and infrastructure in alignment with broader US industrial policy.

So, the on-shoring benefit is not just resilience. It’s a strategic rebalancing of 

Langer: What if someone manufactures under this approach and sells their approval?

That can’t happen. The vouchers are non-transferable. They are tied to the specific product and sponsor. Even if ownership changes, FDA oversight and tech-transfer obligations remain.

Langer: What about other preclinical drugs that lose out because they didn’t “win?”

They retain full access to the well-established expedited pathways (Fast Track, Breakthrough, Priority Review, Accelerated Approval). The voucher simply adds one more lane for highly mature, strategically aligned programs.

Langer: Can FDA really review in 4 weeks?

Sometimes. If the dossier is complete and clean. The 4-8-week target assumes pre-submission review and flawless CMC. FDA can extend the window when complexity demands it.

Rory Budihandojo, independent good manufacturing practices consultant:

 It is not clear logistically how the FDA can provide resources needed for this short/intense review without impacting other FDA review programs (e.g., may divert resources from FDA’s regular standard review program to this expedited review program). Thus, it may also impact therapies that are currently under review, including the potential of resource allocation from FDA’s other priority review programs, such as the Priority Review Voucher (PRV), which expedite the review to 6 months instead of 10 months.

Another suggestion is for FDA to work with other regulatory authorities (e.g., MHRA) in doing the review, leveraging other resources and trying to harmonize the intra-agencies’ review processes, similar to FDA’s mutual recognition program in leveraging facility inspection of other agencies. Although, the style of FDA inspection might be different than that of the other agency (for example, typically an MHRA inspector has industrial experience, while some FDA inspectors may not have industry experience or a science degree, which is kind of like “knowing how to read about driving the car doesn’t necessarily mean the person can drive the car”).



The FDA Commissioner’s National Priority Voucher (CNPV) pilot program aims to expedite drug and biological product application reviews, reducing timelines from 10-12 months to 1-2 months. While it offers significant opportunities for generics and biosimilars, concerns exist about potential compromises in safety standards and resource allocation. The program encourages on-shoring of manufacturing to enhance supply chain resilience and domestic capacity. However, logistical challenges and resource demands may impact other FDA review programs. The vouchers are non-transferable, ensuring oversight remains with the original sponsor and product.

Five experts in the bio/pharmaceutical industry explore the FDA Commissioner’s National Priority Voucher (CNPV) pilot program.

Industry Expert Panel Weighs CNPV Benefits, Risks, and Readiness: Part II

speech bubbles concept 3d illustration | Image Credit: © frender - stock.adobe.com

 held a discussion with five bio/pharmaceutical industry experts to better understand the impacts—both known and potential—of the FDA Commissioner’s National Priority Voucher (CNPV) pilot program (1). The program offers an "unprecedented opportunity to reduce drug and biological product application or efficacy supplement review times from 10-12 months to just 1-2 months" (2,3). While FDA Commissioner Marty Makary, MD, MPH, called CNPV a “common-sense approach” that harnesses a "tumor board style" discussion to deliver "more cures and meaningful treatments to the American public” (3), experts in public health and regulatory policy (1,4-6), warn that this acceleration may come at the expense of established safety standards and fiscal responsibility. Following is a recap of the first half of the discussion, moderated by Eric Langer, president and managing partner, BioPlan Associates. Look for Part II, scheduled for posting on Monday, Nov 24.

Langer: How do companies shift their internal playbook to ensure aligned market access, manufacturing, supply chain, labeling, pricing, and post-approval readiness?

 I have helped one of the voucher winners with their application and paperwork, and now with getting them ready for the project.What is most important for generics and biosimilars selected to receive a voucher is careful planning… Reviews under this program will occur on a rolling basis with increased interaction between the sponsor and the review team. This is a paradigm change, especially for generics, that needs better understanding.

Note that the FDA expects that chemistry, manufacturing, and controls (CMC) information and labeling will be provided 

 60 days before the formal submission. Thus, in the case of some generic products, CMC information could be provided many months in advance, and bioequivalence may be the only major remaining issue to address after the formal submission, and for certain injectable products, even that may not be necessary. Ultimately, these reviews will resemble “first-cycle approvals,” the only difference being that the Agency works closely with the sponsor to resolve all issues well before the actual submission is filed.

Therefore, the reduction in formal review time does not imply that product development, marketing preparation, or post-approval planning must also be compressed proportionally. Instead, sponsors will need to advance market access, pricing, and post-approval readiness activities in parallel, starting with perhaps the first meeting with FDA on the requirements of the application and plausible submission timelines, while maintaining ongoing communications with the FDA review team regarding the progress of the project.

Metin Çelik, PhD, president, Pharmaceutical Technologies International, Inc (PTI):

 Market access strategy, pricing scenarios, health economics and outcomes research models, and payer engagement must begin during late-phase clinical development—not after filing. Labeling strategy and competitive positioning require early alignment, because the opportunity for iterative dialogue with FDA becomes limited. Manufacturing and supply chain readiness (tech transfer, process performance qualification, control strategy, domestic/dual sourcing, quality system robustness) must be essentially complete at submission. Teams need to operate through integrated readiness “war rooms” with weekly cross-functional reviews across CMC, regulatory, safety, medical, commercial, and supply chain.
In this environment, proactive inspection preparation becomes mission critical. This is where systems like my PAIex (Pre-Approval Inspection Expert System) become extremely valuable, as they provide structured risk assessments, documentation frameworks, and predictive readiness analytics aligned with FDA expectations. With a potential 30–60-day review, there is no time to fix compliance gaps once the file is submitted.

What are the regulatory/risk implications of compressed review timelines?

 Most drugs receiving vouchers appear to be generics. I am not aware of such products having received vouchers in the past. However, FDA has substantial experience conducting expedited reviews for numerous new chemical entities that received vouchers. The recent reorganization of the review divisions was designed to ensure that expert teams have the necessary depth of experience to meet expedited review timelines, no matter whether it is for a generic, biosimilar or biologic.

As stated, many of the products awarded vouchers are already generic, and if you read the program carefully, you will see that a company who has received the voucher can move at its own pace. The purpose of these vouchers is to incentivize domestic manufacturing of certain critical drugs without cutting corners related to product development or quality. FDA is supporting domestic manufacturing by providing sponsors with enhanced opportunities for communication before a “formal” submission and thus reducing the approval time significantly for such products.

What sponsors need is a shift in mindset to take advantage of this support. They should treat these pre-submission interactions as “information requests” or "discipline-specific" inquiries, which they are used to getting after the submission of the dossier, and as product and process development progresses, adjusting expectations for commercial timelines according to where they stand with the submission timeline. In these cases, we need to remember that by the time the new drug application (NDA), biologics license application, abbreviated NDA, or related supplements are submitted, both the sponsor and the Agency should already have resolved key risks, making approval largely a formality.

From a risk and compliance perspective, compressed timelines amplify every weakness in a company’s quality risk management (QRM) framework. With less time for iterative review and data verification, risks can easily migrate downstream, into supply chain, labeling, or post-market surveillance. The best-prepared organizations use QRM not only as a compliance tool, but as a decision-making compass, identifying which activities are critical to product quality and patient safety and which can safely be accelerated or deferred.

In recent history, we saw similar dynamics during the rapid COVID authorizations: speed is achievable, but only when quality systems, digital validation, and documentation discipline are built to scale with it. Companies that invested early in these capabilities entered the market faster and more safely.

Compressed reviews shift the risk landscape... There is more reliance on post-market commitments, including safety studies, registries, or risk evaluation and mitigation strategy adjustments, because uncertainties cannot be resolved during the short review. There is also greater operational exposure around scale-up, process robustness, and supply reliability, especially for biologics or GLP-1-class products. Companies mitigate these risks by:

Investing early in CMC strength and supply chain resilience.

Preparing post-approval study proposals in advance to align expectations.

Using digital tools, modeling, AI, and structured inspection-readiness systems, such as PAIex, to anticipate and close gaps before filing.

FDA Awards Second Batch of National Priority Vouchers

The FDA Commissioner's National Priority Voucher (CNPV) pilot program aims to significantly reduce drug and biological product review times, offering a strategic advantage for generics and biosimilars. However, this acceleration raises concerns about maintaining safety standards and fiscal responsibility. Companies must adapt their strategies for market access, manufacturing, and post-approval readiness to align with the expedited timelines. Effective quality risk management and proactive inspection preparation are crucial to mitigate risks associated with compressed review periods. The program incentivizes domestic manufacturing while emphasizing the importance of early communication with the FDA.

Five bio/pharmaceutical industry experts discuss the impacts of the FDA Commissioner’s National Priority Voucher (CNPV) pilot program.

Industry Expert Panel Weighs CNPV Benefits, Risks, and Readiness: Part I

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The FDA Commissioner’s National Priority Voucher (CNPV) pilot program represents a tectonic shift in the expectations placed upon biopharmaceutical sponsors seeking market entry (1). The program, which utilizes a "collaborative tumor board style review process" and a "multidisciplinary team-based evaluation," offers the benefit of reducing application review times from the traditional 8-12 months to "just 1-2 months" following submission (1,2). As Commissioner Marty Makary, MD, MPH, stated, the process is intended to use a “common-sense approach... so that we can reduce inefficiencies" and harness a "tumor board style" discussion to deliver "timely decisions for drug developers" (2). However, this unprecedented acceleration mandates that companies must entirely dismantle the traditional sequential launch model and replace it with a demanding framework of pre-submission completion and parallel cross-functional execution, according to industry experts we spoke with.

Does the CNPV program require a shift to a parallel execution model?

The most critical realization for CNPV applicants is that the compressed timeline eliminates the luxury of sequential product launch activities. In a 

 interview, Henrik Johanning, senior vice president, Quality & Strategy, Epista Life Science, summarizes this radical necessity, stating “When review windows shrink from 10-12 months to as little as 1-2 months, the entire model for launch readiness changes.” He stresses that “the traditional sequential approach, in which regulatory, chemistry, manufacturing, and controls (CMC), labeling, and market access teams work in turn, no longer works."

To succeed under this accelerated timeline, Johanning says companies need to “shift to a parallel execution model, in which quality, regulatory, and commercial readiness progress in lockstep.” This shift, he notes, “demands mature governance and disciplined cross-functional coordination long before submission.” Metin Çelik, PhD, president, Pharmaceutical Technologies International, Inc (PTI), reiterates this point in a 

 interview, stating unequivocally that when the regulatory clock compresses, companies “must fundamentally shift key launch-readiness activities to the pre-submission stage.”

This necessity entails a high degree of integration across internal departments, Çelik adds, which should operate through “integrated readiness ‘war rooms’ with weekly cross-functional reviews across CMC, regulatory, safety, medical, commercial, and supply chain.” The ultimate determinant of success in this accelerated environment, according to Johanning, is not the voucher itself, but “how companies structure their internal control and decision-making models to make compressed reviews sustainable.”

Why is pre-submission perfection in CMC and quality systems so critical?

The cornerstone of the CNPV's speed is the mandatory pre-submission requirement: participants must submit the CMC portion of their application (or efficacy supplement [ES]) and their proposed labeling "at least 60 days before submitting their complete application/ES" (1,2). This front-loading of technical information means that manufacturing and quality robustness must be near perfection at the time of filing.

Çelik clarifies that manufacturing and supply chain readiness, encompassing “tech transfer, process performance qualification, control strategy, domestic/dual sourcing, quality system robustness, …must be essentially complete at submission.” The penalty for non-compliance, he adds, is severe given the time constraint, “with a potential 30-60-day review, there is no time to fix compliance gaps once the file is submitted.” Johanning adds that compressed timelines “amplify every weakness in a company’s quality risk management (QRM) framework.” Therefore, he continues, the most prepared organizations "use QRM not only as a compliance tool, but as a decision-making compass."

Companies must mitigate these risks proactively. Çelik recommends that they “invest early in CMC strength and supply chain resilience” and utilize systems for “structured risk assessments, documentation frameworks, and predictive readiness analytics aligned with FDA expectations.” Johanning advises that sponsors “run a risk-based readiness sprint before applying.” This sprint, he says, involves critical steps like locking “CMC and control strategies, verifying tech-transfer and supply-chain qualification (ideally US-based), aligning labeling and process validation plans, and ideally rehearsing day-0 to day-30 responses,” because “the clock starts the moment you file.”

, Aloka Srinivasan, principal and managing partner at Raaha LLC—who has helped a CNPV winner with their application and paperwork and is now getting them ready for the project—reinforces that while the formal review time shrinks, it “does not imply that product development, marketing preparation, or post-approval planning must also be compressed proportionally.” Instead, the expectation is that by the time the application is submitted, “both the sponsor and the Agency should already have resolved key risks, making approval largely a formality.” For generic products, Srinivasan notes, the CMC information could be provided “many months in advance,” leaving bioequivalence as potentially “the only major remaining issue to address after the formal submission.”

The complexity also extends to external logistics, such as facility inspections. Rory Budihandojo, an independent good manufacturing practices consultant, notes in a 

 interview that it is "not clear how the FDA [alters] other activities to get the drugs to the market faster (e.g., getting the pre-approval inspection, or PAI, coordinated within that 1-2 months frame)." This uncertainty further pressures sponsors to ensure proactive inspection preparation, which Çelik calls "mission critical."

How must commercial and pricing strategies integrate with the CNPV’s affordability mandate?

Beyond technical readiness, commercial and market access strategies must also be accelerated. Çelik insists that “market access strategy, pricing scenarios, health economics and outcomes research (HEOR) models, and payer engagement must begin during late-phase clinical development—not after filing.” Furthermore, he says, "labeling strategy and competitive positioning require early alignment because the opportunity for iterative dialogue with FDA becomes limited." Srinivasan confirms that sponsors “will need to advance market access, pricing, and post-approval readiness activities in parallel.”

Crucially, commercial strategy must integrate one of the CNPV’s explicit criteria: Increasing affordability (1). FDA specifies that this “could include a company that lowers the U.S. price of a drug or reduces other downstream medical utilization to lower overall healthcare costs” (1,3) Makary also notes that vouchers are granted when the company has "agreed to increase affordability" (4).

Sarah Emond and Daniel Ollendorf characterized this focus on cost as a “marked and notable departure for the FDA, an agency that has been clear in the past that drug costs are not its purview or responsibility” in 

 (3). They noted that the Makary’s statement included the concept of agreeing to price the drug under “Most Favored Nation” drug pricing, pointing out that this concept is “problematic because the United States is frequently where new drugs are launched first, so in most cases, there would not be any other prices to reference” (3). Instead of relying on foreign pricing mechanics, Emond and Ollendorf proposed an innovative solution: "drugs approved through the pathway should be required to be priced to value," an approach they said ensures that “a price charged society by the drug manufacturer is tied to how much better it makes patients feel” (3).

Emond and Ollendorf explained that the use of cost-effectiveness analysis, a cornerstone of value assessment, “can summarize the costs a new drug would introduce to the system, the savings it might provide by keeping patients out of the hospital or emergency room, and how it might improve both survival and quality of life during treatment” (3). This analysis “can suggest a fair and affordable price for the benefits a drug provides, which aligns with the spirit of the Commissioner's statement” (3). Companies seeking the CNPV must prepare to demonstrate alignment with these affordability metrics during the late stages of clinical development, long before the application is submitted, adds Çelik.

How should companies leverage enhanced communication and adjust regulatory mindsets?

A key benefit provided to CNPV participants is "enhanced communication throughout the review process" and the use of a rolling review (1). This elevated level of interaction is designed to expedite the process by proactively addressing issues.

Srinivasan characterizes this interaction as a “paradigm change, especially for generics, that needs better understanding.” She states that generic companies that “are usually not used to communicating with the Agency to the extent that do new drug sponsors, will now need to change their mindset and be ready to do so.”

Sponsors must treat these frequent pre-submission discussions strategically, Srinivasan says, advising sponsors to “shift in mindset to take advantage of this support,” treating these interactions as they would handle "information requests" or “discipline-specific” inquiries received after the submission of the dossier. For non-complex generics, this communication represents a “rare luxury as a sponsor of such products has very few ways of communicating with the Agency prior to submission,” she adds. The CNPV, says Srinivasan, guarantees “numerous opportunities to discuss the product and process with the Agency prior to submission of the dossier and the expectation is that by the time they submit the dossier, hopefully most of the issues have been resolved.”

Where does the strategic benefit of onshoring drug development lie?

A primary national priority driving the CNPV program is “onshoring drug development and manufacturing to advance the health interests of Americans and strengthen U.S. supply chain resiliency” (1,2). This priority, according to FDA, addresses the concern that "the vast majority of the active pharmaceutical ingredients and drug components in Americans’ everyday medicines are supplied from China" (2).

Johanning details the strategic goals of the onshoring criteria, explaining that the FDA is using the program “to steer advanced manufacturing, especially sterile injectables and biologics, back to the US.” The overarching objective, he says, is “to rebuild domestic pharmaceutical capacity after decades of off-shoring to Asia and Eastern Europe.” Specific aims, he continues, include reducing “strategic dependency on single-region, non-U.S. suppliers for APIs and sterile products,” safeguarding “critical manufacturing know-how,” and encouraging “modernization, using US-based continuous-manufacturing or single-use technologies.” Furthermore, according to Johanning, US-based facilities “are easier for FDA to inspect, monitor, and support during scale-up or remediation.” This effort, adds Budihandojo, also provides incentives for firms to "invest and build facilities in the US."

Srinivasan affirms that the on-shoring benefit is “especially high for generics and biosimilars,” granting them the valuable “significant opportunities to communicate with FDA prior to their submissions.” Johanning clarifies that the focus is less about nationality and “more about where and how you produce.” Thus, foreign firms with "mature GMP systems" can qualify as “voucher-ready” if they "can demonstrate US manufacturing capacity, tech-transfer readiness, and quality oversight aligned with FDA expectations." The CNPV offers a faster path to market for companies that execute this parallel model effectively, provided they have performed the requisite “careful planning,” concludes Srinivasan.

FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests

The FDA Commissioner’s National Priority Voucher (CNPV) pilot program significantly accelerates the drug approval process, reducing review times from 8-12 months to 1-2 months. This necessitates a shift from traditional sequential launch models to parallel execution, requiring pre-submission completion and cross-functional coordination. Companies must ensure manufacturing and quality systems are robust at submission, as compliance gaps cannot be addressed post-submission. The program also emphasizes affordability and onshoring drug development, encouraging U.S.-based manufacturing to enhance supply chain resilience and reduce dependency on foreign suppliers.

Industry experts weigh in on the CNPV's demands for flawless CMC pre-submission, affordable pricing, expanded communication, and more.

1. What is the current primary driver behind excipient innovation?

Innovation in excipients is explicitly needed

 to meet current drug development demands. They are crucial for addressing challenges in formulation and drug delivery, particularly in optimizing 

 bioavailability, a main challenge for developers.

2. How do excipients facilitate shifts in formulation?

 and hypothesis-driven strategies to generate efficient solutions. Excipients are the physical components manipulated in this process to optimize drug delivery.

3. How are excipients utilized in advanced dosage forms?

Excipients are integral to specialty dosage drugs. For instance, 

Excipients are increasingly pivotal in drug development, addressing formulation challenges and optimizing drug delivery. They are essential in advanced dosage forms, such as 3D-printed tablets, and are influenced by regulatory decisions, which can significantly impact pharmaceutical products. Quality assurance in drug manufacturing is closely tied to excipient quality, necessitating flexible CMC processes. Supply chain pressures and regionalization strategies affect excipient sourcing, while digitalization and AI/ML are transforming excipient selection and manufacturing. Sustainability goals are also reshaping excipient use in pharmaceutical development.