Pharma5: 5 Program Updates After the Recent FDA Overhaul
- By BSTQ Staff
In This Article:
The years 2025 and 2026 have been marked with upheaval at the U.S. Food and Drug Administration (FDA). Five doctors were named director of the Center for Drug Evaluation and Research throughout 2025,1 and Marty Makary, MD, resigned from his position as the commissioner in May 2026.2
Despite the changes, FDA continues to roll out the planned initiatives. Here’s where some of those programs stand today.
Commissioner’s National Priority Voucher (CNPV) Pilot Program
FDA was met with concern upon announcing CNPV in June 2025. The program intends to drastically shorten the drug review timeline from 10 to 12 months to one to two months.3 Industry was generally in favor of the idea, but concerns were raised by public health experts and doctors. In October 2025, FDA announced nine sponsors received the first vouchers.4
Then, FDA held a public hearing on June 4, 2026, and feedback remained the same. Ginny Beakes-Read, head of global regulatory policy at Johnson & Johnson, said the J&J experience “reflected a highly collaborative review process with close engagement between FDA and J&J.”5
Meanwhile, Peter Lurie, MD, president and executive director of the Center for Science in the Public Interest, maintained there are “concerns about politicization in voucher selection and review, strained agency resources and lack of transparency.”5
Additionally, patient advocates voiced praise for the shorter timelines with a desire for a process informed by patient voices.5
FDA PreCheck Pilot Program
The goal of FDA’s PreCheck Pilot Program is to strengthen the U.S. pharmaceutical supply chain. The voluntary program allows FDA to collaborate directly with manufacturers in the initial facility development phases to ensure facilities comply with requirements needed to pass reviews and inspections.
During Phase I, the facility readiness phase, facilities may ask FDA for technical advice before becoming operational. The program is intended for new facilities in development and is not tied to product submissions.
Phase II is the application submission phase during which FDA will work with applicants before submission to build upon what was established in Phase I and conduct pre-submission meetings to resolve potential issues. The goal of this phase is to expedite manufacturing information assessments required in drug application and inspections.
In June 2026, FDA announced seven participating companies: Amneal, Cellares, Eli Lilly, Fujifilm Biotechnologies, Kriya Therapeutics, Kyowa Kirin and Regeneron.6
While there is general industry support for the program, some concerns remain. All of the changes in FDA leadership make some wonder if the scalability of the program is possible, especially during a time of cutbacks in the workforce across the nation. Because the program requires several departments to collaborate, there are other concerns about strategy and consistency.7
Reducing Animal Testing in Drug Development
In April 2025, FDA published a roadmap to eliminate animal testing in preclinical safety studies with scientifically validated new approach methodologies (NAMs), such as organ-on-a-chip systems, computational modeling, and advanced in vitro assays. With this, FDA can accelerate validation and adoption of these human-relevant methods to improve predictive accuracy while reducing animal use.
FDA’s April 2026 update claims it has seen success in this endeavor by releasing draft guidance reducing nonhuman primate testing in antibody development, reducing animal use for FDA approval in drugs that have been demonstrated as safe based on use in humans in other countries, and leveraging an artificial intelligence-based drug development tool, among others.9
Still, challenges remain. Since animal testing has been the standard for decades, researchers will need specific NAM training, and smaller laboratories may not be able to invest due to cost.10
Pre-Approval Inspection (PAI) and Pre-License Inspection (PLI)
FDA’s PAI and PLI programs are used to check whether manufacturing facilities are ready to produce drugs and biologics that meet approval standards. Inspectors review manufacturing operations, quality systems, data integrity and process controls, confirming that actual practices match what is stated in the marketing application.
The programs aim to ensure manufacturers can consistently deliver safe, effective, high-quality products under current good manufacturing practice requirements. FDA may also use alternatives such as remote regulatory assessments when suitable, allowing oversight to continue without an in-person inspection.
FDA published the new PLI compliance program in April 2026, followed by the revised PAI compliance program in June 2026. These revisions address FDA’s risk-based approaches to inspections.11
Rule Proposal to Modernize Drug Manufacturing Registration
FDA proposed a rule on July 10, 2026, to modernize drug manufacturing registration in two main ways: distributed manufacturing registration and foreign establishment registration.
Through distributed manufacturing (“hub-and-spoke”) registration, manufacturers using a central hub with multiple production units at different sites could register as a single establishment, rather than registering each unit separately. Companies would still need to notify FDA before relocating any unit, closing an oversight gap.
Foreign establishment registration would clarify that foreign facilities producing drugs or active pharmaceutical ingredients solely for distribution to other foreign establishments must register with FDA, even if the product only indirectly enters the U.S. supply chain. This is meant to close a visibility gap in upstream/foreign supply sources.
FDA officials framed the changes as aligning regulation with how distributed manufacturing actually operates and improving traceability of ingredients reaching American patients. If finalized, the rule is expected to cut registration costs for distributed manufacturers and create long-term efficiencies, building on broader efforts to strengthen domestic drug manufacturing and supply chain transparency.12
References
- Glibney, M. 5 CDER Directors in One Year? Turnover Threatens ‘Institutional Memory’ at U.S. Health Agencies. PharmaVoice, Dec. 16, 2025. Accessed at www.pharmavoice.com/news/fda-cder-directors-turnover-institutional-memory-health-agencies/807982.
- Incorvaia, D. Makary’s FDA Reforms ‘Continue to Move Forward’ Despite Leadership Turmoil. Fierce Biotech, May 26, 2026. Accessed at www.fiercebiotech.com/biotech/makarys-fda-reforms-continue-move-forward-agency-adjusts-leadership-turnover.
- Craven, J. Stakeholders Offer Suggestions for Improving FDA’s CNPV Program. Regulatory Affairs Professionals Society (RAPS), June 4, 2026. Accessed at www.raps.org/resource/stakeholders-offer-suggestions-for-improving-fda-s-cnpv-program.html.
- FDA Awards First-Ever National Priority Vouchers to Nine Sponsors. U.S. Food and Drug Administration news release, Oct. 16, 2025. Accessed at www.fda.gov/news-events/press-announcements/fda-awards-first-ever-national-priority-vouchers-nine-sponsors.
- Incorvaia, D. At First Public Hearing for FDA’s CNPV Program, Industry Support Meets ‘Deep Concern’ From Experts. Fierce Biotech, June 5, 2026. www.fiercebiotech.com/biotech/first-public-cnpv-hearing-support-industry-and-deep-concern-experts.
- S. Food and Drug Administration. FDA PreCheck Pilot Program. Accessed at www.fda.gov/industry/fda-precheck-pilot-program.
- Lundin, A. FDA Precheck Pilot Draws Industry Support as Questions on Execution Remain. Pharma Manufacturing, June 2, 2026. Accessed at www.pharmamanufacturing.com/compliance/article/55381327/fda-precheck-pilot-draws-industry-support-as-questions-on-execution-remain.
- S. Food and Drug Administration. Roadmap to Reducing Animal Testing in Preclinical Safety Studies. Accessed at www.fda.gov/media/186092/download?attachment.
- FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development. U.S. Food and Drug Administration news release, April 20, 2026. Accessed at www.fda.gov/news-events/press-announcements/fda-achieves-year-1-goals-reducing-animal-testing-drug-development.
- Craven, J. Experts Say FDA’s Plan to Reduce Animal Testing is Already Seeing Success at 1 Year, But Challenges Remain. Regulatory Affairs Professionals Society, June 25, 2026. Accessed at www.raps.org/resource/experts-say-fda-s-plan-to-reduce-animal-testing-is-already-seeing-success-at-1-year-but-challenges-remain.html.
- S. Food and Drug Administration. FDA Actions to Support and Strengthen Domestic Drug Manufacturing. Accessed at www.fda.gov/industry/fda-actions-support-and-strengthen-domestic-drug-manufacturing.
- FDA Proposes to Modernize Drug Manufacturing Registration. U.S. Food and Drug Administration news release, July 10, 2026. Accessed at www.fda.gov/news-events/press-announcements/fda-proposes-rule-modernize-drug-manufacturing-registration.