Comparing the new Commissioner's National Priority Voucher Program review timeline with existing pathways and designations - not too dissimilar from real-time and rolling review mechanisms already in place, but with a much quicker decision date.

Q2 2025 Priority Review Voucher (PRV) Summary: 🏛️FDA announced a new Commissioner’s National Priority Voucher program.📝 $NVS Novartis redeemed a PRV for the remibrutinib NDA.📝 $REGN Regeneron redeemed a PRV for an EYLEA HD sBLA .📝 $NOVO Novo Nordisk likely (unconfirmed)

Four Bills were introduced in Feb/March to reauthorize the Medical Countermeasure PRV and Rare Pediatric PRV Programs. No hearings are currently scheduled to progress the Bills.

Now disclosed via FTC posting, $REGN Regeneron Pharmaceuticals was the purchaser of $ABEO Abeona Therapeutics PRV.

The review shall encompass all regulations/guidance that apply to:.🔹inspection and approval of new and expanded manufacturing capacity.🔹emerging manufacturing technologies .🔹active pharmaceutical ingredients, key starting materials, and associated raw materials in the U.S.

Nov 1st, the FDA Commissioner shall:.🔹take steps to eliminate any unnecessary requirements that pertain domestic manufacturing development.🔹maximize the timeliness and predictability of agency review.🔹streamline and accelerate the development of domestic manufacturing.

I hadn’t made the connection before, but it seems that executive order on May 5, 2025, 'Regulatory Relief to Promote Domestic Production of Critical Medicines,' contributed to the creation of the Commissioner’s National Priority Voucher program. 🧵1/3.

Excerpt from the @HouseCommerce Subcommittee on Health hearing titled ‘The Fiscal Year 2026 Department of Health and Human Services Budget.’

The FDA acknowledged the criticism received following the Commissioner’s National Priority Voucher program announcement. Vinay Prasad remarks “…I’ve also seen some criticism from some of the people in the past who were the biggest proponents of FDA cutting down the bureaucracy.

The last six disclosed Priority Review Voucher (PRV) sales were all over $150M. Todays $160M sale is the highest reported price for a PRV in 9 years

$BAVA.CO Bavarian Nordic just announced that they have sold the Tropical Disease Priority Review Voucher they received in February 2025 for $160M; purchaser not disclosed. The chikungunya vaccine was originally developed by the National Institute of Allergy and Infectious.

Comparison of the different FDA Priority Review Voucher attributes including what we know so far from the FDA Commissioner's National Priority Voucher program announced today.

Here is some meaningless math. When redeeming a PRV, the sponsor has to pay an additional $2,482,446 fee on top of the $4,310,002 application fee, for the additional resource to expedite a 10 month review to 6m. For the new Commissioner’s National Priority Vouchers, if I.

The U.S. FDA today announced a Commissioner’s National Priority Voucher (CNPV) program. The ultimate goal of the program is ‘to bring more cures and meaningful treatments to the American public.’. The new CNPV program will:.- shorten review timeline from 10-12 months to 1-2.

For an up-to-date tracker of Priority Review Voucher issuances, sales and redemptions, check out

Priority Review Vouchers discussed in today's FDA Direct from 25:08 onwards. Transcribed the excerpt below. VP: …and time is money. Shave a year off and you shave off potentially billions of dollars in drug R&D expenditure. MM: If you look at the value of a quicker decision,.

Summary from the First FDA CEO Listening Forum (1 of 5 planned nationwide):.These notes summarize the discussion starting at 21:54 in the video linked below. The feedback has been grouped into three themes: 🔸Communication,🔸Standards,🔸Transparency.🔹Approximately 60–70.

A couple of mentions of the Priority Review Voucher Program in todays FDA Cell and Gene Therapy Roundtable:. President of American Society of Gene and Cell Therapy:.". The FDA's rare disease pediatric priority review voucher program, the PRV, provides incentives for life-saving.