Christopher Cole

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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”).



Commissioner's National Priority Voucher (CNPV) Pilot Program

FDA Commissioner’s National Priority Vouchers Will Endanger Americans

Questions Remain as FDA Opens Submissions for New Priority Voucher Program

How to Make One Line in the FDA Commissioner's New Drug Review Program Into a Force for Affordable Access for Patients

Articles

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

Business multitasking and time management vector illustration in flat style | Image Credit: © markusmiller - stock.adobe.com

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, 

 are being developed to achieve precise, delayed delivery for specific treatments, which requires highly specialized excipient properties.

4. What are the primary regulatory challenges facing excipient suppliers and pharmaceutical developers?

 regarding specific ingredients can have profound impacts. A ban on ingredients, 

such as the potential titanium dioxide ban

, could have significantly crippled pharma products.

5. How do excipients impact quality assurance and risk in drug manufacturing?

Excipient quality affects overall quality assurance/quality control. Strategies for accelerating development and reducing risk 

require maintaining a flexible CMC process that ensures quality

6. How are pressures and regionalization affecting excipient sourcing?

Supply chain pressures, including the strategy of achieving a 

, are crucial strategies for optimizing efficiency and 

affect small molecule development and excipient use

7. How is digitalization impacting the excipient side of manufacturing?

The emerging prevalence of digitalization is a 

 handling excipients. Digital transformation and data integrity protocols are 

 for optimizing drug development and manufacturing efficiency.

8. How are AI and Machine Learning (ML) being used to improve excipient selection?

mastering AI capabilities and data integration

 to optimize bio/pharmaceutical manufacturing. Specifically

 can accelerate poorly soluble drug development, which often requires specialized excipient strategies (like 

9. What is the link between excipient selection and pharmaceutical sustainability goals?

 to meet client expectations and climate pressures. Sustainability is a specific factor reshaping 

small molecule development and excipient use

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.

FAQ: Everything to Know About Excipients in the Digital Era

Editor's Note: 
Stay tuned for additional coverage and industry expert perspectives on how the CNPV program'

 ultra-fast review forces firms into a parallel execution mode, posting tomorrow. And check out "



The introduction of the FDA Commissioner’s National Priority Voucher (CNPV) pilot program in 2025 has ignited intense debate regarding the balance between speed and scientific rigor in drug review (1-4). 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" (5,6) (Figure). FDA Commissioner Marty Makary, MD, MPH, championed this effort, calling it a “common-sense approach” that harnesses a "tumor board style" discussion to deliver "more cures and meaningful treatments to the American public” (6). However, experts in public health and regulatory policy (1-4), as well as several industry experts who we spoke with, warn that this acceleration may come at the expense of established safety standards and fiscal responsibility.

How are safety standards and independent regulatory scrutiny affected?

The most significant public health critique comes from those who fear that compressed timelines inherently increase risk. Doctors for America released a statement calling the CNPV program "a very bad idea," with "vague criteria" that "will endanger Americans" (1).

Dr. Robert Steinbrook, Director of Public Citizen Health Research Group, stated definitively: “The priority voucher program is not a ‘common sense’ approach as the FDA Commissioner claims, but a dangerous one” (1). Dr. Steinbrook cited research demonstrating that "when the FDA rushes to review and approve new drugs, there is a higher likelihood that these drugs will have safety problems after approval." He concluded that the CNPV program "will only be a boon for Big Pharma at the expense of the American public."

Furthermore, the fast-track nature is perceived to threaten external review mechanisms. Dr. Steinbrook also noted that the program "will likely bypass the agency’s advisory committee process that allows for outside independent input” (1). Echoing concerns about transparency and patient trust, Dr. Reshma Ramachandran, a member of the Board of Directors of Doctors for America, questioned: “How can patients and clinicians trust that drugs approved with one to two months of review are truly safe and effective?” (1).

What logistical and resource allocation challenges are introduced?

The CNPV challenges FDA’s long-established performance goals under the Prescription Drug User Fee Act (PDUFA), which commits the agency to reviewing priority applications within six months and standard applications within 10 months following the 60-day acceptance period (8). Achieving a consistent one- to two-month timeline necessitates a radical rethinking of resource allocation.

Rory Budihandojo, an independent good manufacturing practices consultant, questions the operational feasibility, stating it is "not clear logistically how the FDA can provide resources needed for this short/intense review without impacting other FDA review programs" in an interview with 

. He elaborates that this acceleration "may divert resources from the FDA’s regular standard review program to this expedited review program." This diversion could impact other crucial therapies, including those under the statutory Priority Review Voucher (PRV) program, which "expedite the review to 6 months instead of 10 months."

In a client alert dated Sept 29, 2025, David Dorsey, strategic advisor, and Stephen Holland, senior counsel, both at the law firm Brownstein, noted the logistical challenges of CNPV, stating that FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research already "struggle to meet certain PDUFA goals," particularly those related to meetings with sponsors, producing meeting summaries, and responding to follow-up questions within mandated time limits (4). These pre-existing struggles, wrote the authors, are likely to be "aggravated, by the resource needs of the CNPV program"(4).

A significant financial trade-off is the lack of a dedicated funding mechanism, according to Dorsey and Holland. Unlike the statutory PRV programs established by Congress, which require the payment of an "extra user fee on top of any other application fee to provide for the additional resources needed to conduct a priority review…, no similar fee would exist for the CNPV program," they wrote, indicating that this means the entire resource cost must be absorbed internally through reallocation (4).

What are the associated scientific and operational challenges?

To compensate for the compressed review timeline, the CNPV program requires sponsors to submit chemistry, manufacturing, and controls (CMC) information and proposed labeling at least 60 days prior to the formal application filing (5). This front-loading is intended to allow reviewers to begin analysis ahead of submission.
But Dorsey and Holland emphasize that this requirement introduces scientific and procedural challenges. “It is impossible to write and review a drug label without a thorough understanding of all the clinical trial data,” they wrote, adding that pre-submission labeling review may effectively ask reviewers to evaluate claims for which final clinical data are not yet available, “putting the cart before the horse.”
Operationally, the compressed timeline also raises questions about coordinating pre-approval inspections (PAIs), which are required for new products and manufacturing sites. Budihandojo questions whether inspection scheduling could realistically be compressed into the same 1-2-month window.
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—adds nuance in an interview with 

, stating that for many generics, especially non-complex sterile injectables, CMC work can occur months before filing, leaving bioequivalence as the only major outstanding issue. In such cases, she argues, the CNPV structure may support what is essentially a “first-cycle” approval based on extensive pre-submission interactions.
Still, Srinivasan emphasizes that companies must overhaul their development model to take advantage of the voucher. “The reduction in formal review time does not imply that product development, marketing preparation, or post-approval planning must also be compressed proportionally,” she explains. Instead, organizations must begin market access, pricing, supply-chain qualification, and labeling strategy in parallel with regulatory interactions rather than sequentially.
In an interview with 

, Metin Çelik, PhD, president, Pharmaceutical Technologies International, Inc (PTI), summarizes the shift in risk, noting that compressed reviews mean reduced iterative interaction with the FDA, which "places more pressure on a flawless first submission." The result is “more reliance on post-market commitments, including safety studies, registries, or [risk evaluation and mitigation strategy, or REMS] adjustments, because uncertainties cannot be resolved during the short review,” Çelik adds.

What are the sponsor organizational readiness and preparedness differences?

One of the clearest takeaways from the industry experts we spoke with is that the CNPV does not merely test FDA readiness, it tests sponsor readiness. The voucher only benefits companies that enter the process with mature governance systems, integrated quality risk management, strong digital validation capabilities, and robust pre-submission preparation (5).
Henrik Johanning, senior vice president, Quality & Strategy, Epista Life Science notes in an interview with 

 that compressed timelines “amplify every weakness in a company’s QRM framework.” He explains that risks can easily spill into manufacturing, supply chain, labeling accuracy, or post-market surveillance when iterative review cycles are shortened.
Drawing parallels to COVID-era emergency authorizations, Johanning argues that speed is possible, but only when supported by scalable digital documentation, disciplined cross-functional governance, and deeply integrated CMC and regulatory planning.
Çelik emphasizes that the compressed environment requires “integrated readiness war rooms” and that nearly all manufacturing and supply-chain readiness must be completed before filing. With only 30-60 days for FDA review, “there is no time to fix compliance gaps once the file is submitted,” he warns.

What are the discretion, incentive, and transparency concerns?

The discretionary nature of the CNPV award raises questions about the program’s foundation and ultimate incentives, wrote Dorsey and Holland. The CNPV award is "entirely discretionary and based on largely undefined criteria," they wrote (4).

Budihandojo suggests that the program transparency itself "might be in question; as this is based on the commissioner’s discretion and decision, it may be political based and not just based on science and public need." An industry expert with whom 

spoke and who asked to be anonymous, added that attempting to "define and demonstrate the elements" in the program’s parameters, such as to “increase affordability, domesticate manufacturing as a national security issue, or address an unmet public health need,” could be "open to interpretation." Eric Langer, president and managing partner, BioPlan Associates, also notes the "complexity for drug innovators trying to gamble on demonstrating" these elements, in an interview with 

Dorsey and Holland highlighted that, unlike the statutory PRV programs for which the sponsor knows the criteria and the transferable value (vouchers have recently sold for about $100 million), the CNPV's value as an incentive is questionable (4). Because the award is discretionary and occurs late in development, it is "hard to understand the CNPV as incentivizing anything," especially early development decisions like manufacturing location, they stated (4). The non-transferability (7) and the requirement to use the voucher within two years (7) further limit its appeal, meaning "small biotech companies are less likely to benefit from a CNPV," they added (4).

Despite these risks, FDA Principal Deputy Commissioner Sara Brenner, MD, MPH, maintained confidence, asserting in a news release that the "more efficient process can be achieved without cutting any corners on safety or scientific evaluation” (6). The FDA retains a critical safeguard: the right to extend the review window if data or application components are "insufficient or incomplete," if pivotal trial results are "ambiguous," or if the review is "particularly complex" (5,6).

FAQs: Commissioner’s National Priority Voucher Pilot Program

The FDA's National Priority Voucher (CNPV) pilot program aims to expedite drug review times significantly, reducing them from 10-12 months to 1-2 months. While this initiative promises faster access to treatments, it raises concerns about compromising safety standards and bypassing independent regulatory scrutiny. Critics argue that the accelerated timeline could lead to safety issues post-approval and strain FDA resources. The program's discretionary nature and lack of dedicated funding further complicate its implementation, potentially limiting its appeal and effectiveness, especially for smaller biotech companies.

FDA’s CNPV pilot aims to speed drug reviews but raises questions about safety trade-offs, resource strain, and unclear incentives for sponsors.

FDA announced on Nov 06, 2025, the award of its second batch of Commissioner’s National Priority Vouchers (CNPV) pilot program recipients (1). This cohort adds six awardees, bringing the total number of voucher recipients to 15. According to the Nov 6 news release, the agency is committed to accelerating the review of products that address key national priorities. FDA Commissioner Marty Makary, MD, MPH, stated that the agency is "pioneering new ways of bringing these cures and meaningful treatments to the market faster" (1).

These vouchers are highly selective, granted only when the company agrees to increase affordability, domesticate manufacturing (as a national security issue), or address an unmet public health need (1). The core benefit is speed: national priority voucher holders will receive a decision within 2 months, a drastic reduction of the typical review timeline. This accelerated process includes a one-day “tumor board style” meeting, which brings together a multidisciplinary team of physicians and scientists for review. The FDA stated that is authorized to test these innovative regulatory approaches under acts like the 21st Century Cures Act (1).

In light of the pilot programs continued growth and potential impacts on the bio/pharmaceutical industry, we are conducting as survey of industry professionals. This is your critical chance to voice your opinions and professional insights on what the CNPV program means to you, your organization, and the industry as a whole. Participate today and help shape the conversation around innovative regulatory review!

The FDA has awarded its second batch of Commissioner’s National Priority Vouchers (CNPV), adding six new recipients and bringing the total to 15. These vouchers aim to expedite the review of products addressing national priorities, with decisions made within two months. The program requires recipients to enhance affordability, domesticate manufacturing, or meet unmet public health needs. The accelerated review process includes a multidisciplinary "tumor board style" meeting. The initiative is part of the FDA's efforts to innovate regulatory approaches under acts like the 21st Century Cures Act.

Take our survey to voice your opinions on the bio/pharma industry impacts of the FDA Commissioner’s National Priority Vouchers program.