Nicholas Saraceno

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. 

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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

Kedrion Biopharma, a US-based biopharmaceutical company specializing in plasma-derived therapeutics, announced on Nov. 19, 2024 that FDA has approved its manufacturing facility in Bolognana, Italy, to produce Ryplazim (plasminogen, human-tvmh), a plasma-derived human plasminogen indicated for treating patients with plasminogen deficiency type 1 (PLGD-1), or hypoplasminogenemia (1).

PLGD-1 is a rare chronic disease that mainly appears in the form of “abnormal extra-vascular fibrin-rich, ligneous” lesions on various mucosal surfaces throughout the body. Most notably, lesions occur in the eye (known as ligneous conjunctivitis); however, their appearance in the respiratory, gastrointestinal, and genitourinary tracts—along with the central nervous system, ears, mouth, and skin—is not uncommon. They can potentially lead to serious consequences, including obstruction of airways; infertility; and hydrocephalus, along with vision and hearing loss.

"The FDA's approval of our Bolognana facility is a pivotal moment for our company, and I want to thank all employees worldwide who contributed to this achievement," said Bob Rossilli, chief commercial officer, global business and US general manager, Kedrion Biopharma, in a company press release. "This expanded capacity for Ryplazim means we can provide treatment for more patients with PLGD-1. Offering a product like [Ryplazim] to patients in need is truly a privilege."

This development signifies greater patient access to this PLGD-1 medication, not only in the United States, but globally as well. Ryplazim is considered the first and only FDA-approved therapy specifically for the PLGD-1 indication after receiving approval in June 2021; Kedrion officially announced plans to commercialize and distribute the product later that year (2). The active ingredient in Ryplazim is plasminogen, which is purified from human plasma (3). Treatment with Ryplazim helps to increase the plasma level of plasminogen, helping to limit or remove the lesions.

In a single-arm, open-label (unblinded) clinical trial that enrolled 15 adult and pediatric patients with PLGD-1, patients were administered Ryplazim every two to four days for 48 weeks. Overall, the medication’s effectiveness was apparent by at least a 50% improvement of their lesions in all 11 patients who had lesions at baseline, while there were no new lesions in any of the 15 patients through these 48 weeks (3). The most common side effects that patients reported were abdominal pain, back pain, bloating, bleeding, constipation, dry mouth, dizziness, fatigue, limb pain, nausea, headache, and joint pain (3).

"With increased awareness of PLGD-1, the expanded capacity of Ryplazim ensures we are better equipped to meet the growing demand, noted Rebecca Bialas, MD, co-founder and chair of The Plasminogen Deficiency Foundation, in the release (1). “This means more patients who receive the correct diagnosis can be confident they will get the treatment they so desperately deserve and need. This is an exciting time for the PLGD-1 community, marking a significant event in our collective journey towards better health."

1. Kedrion Biopharma. FDA Approves Kedrion's Bolognana Facility for Production of First and Only Treatment for PLGD-1, Ryplazim. Press Release. Nov. 19, 2024.
2. Kedrion Biopharma. Kedrion Biopharma to Commercialize Ryplazim in US. Press Release. Oct. 20, 2021.
3. FDA. FDA Approves First Treatment for Patients with Plasminogen Deficiency, a Rare Genetic Disorder. Press Release. June 4, 2021.

FDA's approval will allow Kedrion to manufacture Ryplazim (plasminogen, human-tvmh), the only FDA-approved therapy for treating PLGD-1, at facility in Bolognana, Italy.

FDA Grants Approval to Kedrion to Produce PLGD-1 Therapeutic at Bolognana Plant

On Nov. 20, 2024, Fujifilm Diosynth Biotechnologies announced the completion of an expansion at its Thousand Oaks, Calif., cell therapy manufacturing facility (1). At a celebration for the opening of the updated facility, the company also recognized the issuance of a Certificate of GMP Compliance of a Manufacturer for the site, granted to it by the European Medicines Agency (EMA).

The investment project was originally announced (2) in December 2023 as one component of the company's $200 million cell therapy development and manufacturing investment project; the plan also involves financially supporting its Fujifilm Diosynth Biotechnologies’ California site, Fujifilm Cellular Dynamics, Inc.’s new headquarters (HQ) in Madison, Wis., and the Cellular Dynamics' new HQ with cell therapy manufacturing services, which is expected to be up and running by 2026.

When it comes to the Thousand Oaks location, the development project features the advancement of the development labs and welcomes two new independent cell therapy production suites to the mix, which boosts cleanroom capacity. The current good manufacturing practice (CGMP) suites are capable of automated cell separation and selection, with expansion equipment, in-built decontamination for rapid changeovers, and heating, ventilation, and air conditioning systems that can support either Grade B or C backgrounds.

Further, these suites can handle either open or closed processing—they’re also large enough to accommodate multiple patients’ autologous program lots, or even greater volume batches for allogeneic programs for both the clinical and commercial marketplaces.

“The completion of the expansion at our California cell therapy facility demonstrates our ability to support the growing needs of our early-to-late-stage allogeneic customers and late-phase autologous customers for commercial cell therapies," said Lars Petersen, president and CEO, Fujifilm Diosynth Biotechnologies, in a company press release (1). “As our industry realizes the promise of precision medicine, we are pleased to be at the ready to support production at our California facility, with the specialized skill and expertise of our team on-site.”

As alluded to previously, the California plant recently was given EMA regulatory approval, specifically for the manufacturing of sterile, biological medicinal products, and quality control testing specifically for Atara Biotherapeutics’ Ebvallo (tabelecleucel or tab-cel), which is a monotherapy that was approved in Europe for adults and children with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (r/r EBV+ PTLD).

Overall, in 2023, the global cell therapy market size was estimated to be valued at $4.8 billion, and forecasts are anticipating that the market will continue to grow at a compound annual growth rate of 37% during 2023 to 2030 forecast period (3).

“I am very proud of our entire team for reaching these important milestones, which will benefit patients that rely on these important cell therapies,” commented Dave Bolish, site head of Fujifilm Diosynth Biotechnologies, California, in the release (1). “The recent EMA GMP certification exemplifies that our high-quality manufacturing processes, systems, talent, and world-class facility meet regulatory requirements, and we have the agency’s trust to manufacture and deliver product on behalf of our partner.”

1. Fujifilm Diosynth Biotechnologies Celebrates the Expansion Completion at its California Cell Therapy Facility. Press Release. Nov. 20, 2024.
2. Fujifilm to Invest USD 200 Million to Expand Cell Therapy Development and Manufacturing Capabilities. Press Release. Dec. 4, 2023.
3. Fujifilm estimates based on Evaluate Pharma November 2023.

The Thousand Oaks, Calif., cell therapy manufacturing facility now houses new production suites, updated development labs, and more after expansion.

Fujifilm's Cell Therapy Facility Expansion Completed

On Nov. 19, 2024, Pharmaceutics International, Inc. (Pii), a contract development and manufacturing organization (CDMO), announced that it is investing $3.6 million into its prefilled syringe (PFS) services, specifically to boost its advanced labeling, automated visual inspection, and fill/finish technology (1). The investment will allow the CDMO to provide end-to-end, streamlined solutions for drug manufacturing.

Pii’s decision was partially influenced by the demand for prefilled syringe solutions in the pharmaceutical and biotech sectors. The aforementioned investment will go towards a syringe labeler, along with an Antares automated visual inspection (AVI) system.

“With this expansion, Pii strengthens its role as a comprehensive partner, allowing clients to achieve faster time-to-market by managing every step of the PFS process,” said John Fowler, Pii’s CEO, in a press release. “Our streamlined approach will support customers in optimizing both cost and quality, meeting stringent regulatory demands, and ultimately improving patient access to essential therapies.”

The branded syringe labeler is in the process of being installed, and is expected to be fully operational by either the first half or early second half of 2025. Essentially, it automates syringe labeling, plunger insertion, and safety device integration.

The concept of combining advanced labeling, automated visual inspection, and fill/finish tech services limits logistical and regulatory complexities when it comes to product delivery timelines. It also helps with quality control, which reduces the risk of errors.

As for the Antares AVI technology, the anticipated operational date is the third quarter of 2025. The system is able to detect air bubbles, cracks, particles, and fill-level discrepancies. It also reportedly decreases dependence on manual inspections, while boosting large-scale production turnaround times, and supporting regulatory requirements that surround quality analysis and traceability.

In other Pii news, over the past year, the company had announced a new leadership team (2) consisting of Joseph Kiely as chief financial officer; George Sanders as vice-president (VP) of human resources, Thomas Pamukcoglu as VP of quality; James Drob as head of aseptic manufacturing; John Phillips as VP of sales; Bob Talley as general counsel and assistant secretary, and Alexander Borodin as senior director of supply chain. Devan Patel was also promoted to VP of client services, while Sara Frederick, joined the team as senior director of business operations.

“I’m delighted to continue this journey of implementing real cultural change within the company. Among their responsibilities will be oversight of new operational processes and systems that will improve our ability to deliver on time and in full,” said Pii CEO John Fowler in a press release issued at the time (2). “Every one of these new team leaders is an incredible addition to our company and an important piece of our company-wide strategy to provide best in class services to our partners.”

1. Pii Expands Prefilled Syringe Services with $3.6M Investment in Capacity and Technology Upgrades. Press Release. Nov. 19, 2024. 
2. Pharmaceutics International Onboards New Leadership Team to Drive Quality, Operational Improvements, and Growth. Press Release. March 20, 2023. 

The $3.6 million investment will allow the CDMO to boost its advanced labeling, automated visual inspection, and fill/finish capabilities.