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Priority review voucher and Food and Drug Administration news and key developments

RPD

April 6, 2026

FDA Budget for 2027 includes proposal to permanently reauthorize the rare pediatric disease priority review voucher program

The President’s FY2027 FDA budget proposal includes several major legislative reforms aimed at accelerating drug development, modernising regulatory processes, and increasing FDA flexibility.

Key proposals include:

creation of a new expedited Investigational New Drug (IND) pathway for certain Phase 1 clinical trials where sufficient preclinical data already exists, partly intended to help the U.S. compete with faster early-stage development pathways in countries such as China and Australia.
permanent reauthorisation of the Rare Pediatric Disease Priority Review Voucher (PRV) program.
granting the FDA greater discretion over Scientific Advisory Panel composition, including whether industry representatives are appointed to advisory committees.
providing explicit authority for the FDA to publicly disclose information contained within Complete Response Letters (CRLs), continuing the agency’s recent push toward greater transparency.
clarifying the legal category and regulatory requirements surrounding compounded drugs, including restrictions on misleading direct-to-consumer advertising.
removing the requirement for comparative clinical efficacy studies for biosimilars and allowing all biosimilars to be automatically interchangeable with their reference products at the pharmacy level.

Overall, the proposals continue the FDA’s broader shift toward faster review timelines, regulatory flexibility, increased transparency, domestic competitiveness, and reduced development burdens for certain products.

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FDA Budget for 2027 includes proposal to permanently reauthorize the rare pediatric disease priority review voucher program

Partner Therapeutics receives FDA approval for Bizengri (zenocutuzumab-zbco) under the Commissioner’s National Priority Voucher pilot program

Commissioner's National Priority Voucher awarded to Bizengri (zenocutuzumab-zbco) for advanced unresectable or metastatic cholangiocarcinoma

FDA awards Commissioner's National Priority Vouchers to three psychedelic products

Regeneron receives approval under the Commissioner's National Priority Voucher for Otarmeni (DB-OTO)

Eli Lilly launches oral GLP-1 Foundayo on TrumpRx

Eli Lilly & Company receives FDA approval for orforglipron, their oral GLP-1 under the Commissioner’s National Priority Voucher program

Notable achievements from Commissioner Makary's first year at the FDA

Commissioner’s National Priority Voucher pilot program public hearing scheduled for June 4th

FDA approves Wegovy (semaglutide) 7.2mg under the Commissioner’s National Priority Voucher program

FDA approves teclistamab and daratumumab from Johnson & Johnson under the Commissioner’s National Priority Voucher program

FDA approves Boehringer Ingelheim’s Hernexeos (zongertinib) under the new Commissioner's National Priority Voucher pilot program

FDA town hall on Commissioner's National Priority Voucher pilot program

Cyprium Therapeutics sell priority review voucher for $205 Million

TrumpRx.gov launches with 43 products

House and Senate extend the rare pediatric disease priority review voucher program to 2029

Sun Pharma has been awarded a rare pediatric disease priority review voucher after being originally denied in 2022

120 years of the U.S. Food and Drug Administration

Updates to Commissioner's National Priority Voucher Frequently Asked Questions

Insights from FDA Commissioner Marty Makary on the All-In Podcast/Interview

Jazz Pharmaceuticals announced a priority review voucher for $200M sale at the annual J.P. Morgan Healthcare Conference

The Give Kids a Chance Act for the rare pediatric disease priority review voucher program fails at the Senate

FDA awards a Commissioner’s National Priority Voucher to Johnson & Johnson for teclistamab in combination with daratumumab

USAntibiotics receives the first approval under the Commissioner's National Priority Voucher program for Augmentin XR

Court rules Sun Pharma should have received a priority review voucher for Sezaby in 2022

The US House passes the Give Kids a Chance Act to reauthorize the rare pediatric disease priority review voucher program

The FDA has now issued >100 priority review vouchers

FDA awards six additional Commissioner’s National Priority Vouchers

FDA awards first Commissioner’s National Priority Vouchers to nine companies

The FDA introduces the Rare Disease Evidence Principles to provide greater speed and predictability in the review of rare disease treatments

FDA accepting applications for the Commissioner’s National Priority Voucher pilot program

Commissioner Makary’s reflections on his first 100 days at the FDA

A look back at the Presidents Executive Order ‘Regulatory Relief to Promote Domestic Production of Critical Medicines’

FDA to award Commissioner’s National Priority Vouchers under a new pilot program aligned with U.S. national interests

FDA signals openness to faster drug approval pathways and greater transparency

Give Kids a Chance Act introduced into Congress to reauthorize the pediatric rare disease priority review voucher program

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