https://www.fiercebiotech.com/biotech/fda-launches-new-priority-review-voucher-biopharmas-align-national-priorities

The FDA is introducing a new priority voucher program designed to shorten the drug review process from 10 to 12 months down to one or two months, according to the agency.

The federal outfit’s “Commissioner’s National Priority Voucher” (CNPV) program will include a “limited number of vouchers” for “companies aligned with U.S. national priorities,” according to a June 17 press release.

Without providing specifics, the FDA said the vouchers will go to companies that are addressing a U.S. health crisis, "delivering more innovative cures," addressing unmet public health needs and boosting domestic drug manufacturing.

"These vouchers are non-transferrable," an FDA spokesperson told Fierce Biotech. "However, they will remain valid through changes in company ownership."


https://www.fda.gov/news-events/press-announcements/faqs-commissioners-national-priority-voucher-program

The Criteria is not yet set in stone but we are good for three out of four so far- then if we manufacture in Houston we won't have a problem, young ones may miss that joke. Heaven's above Opioid Crisis - number one cause - back pain. Unmet needs - Adult SR aGvHD Grade 111/IV - Meetings with FDA early July- if you missed it , I wondered why the type of meeting scheduled for early July was not given a Type ie meeting with the FDA foe a Type B meeting. Tell me that the adult unmet need trial does not fit the brief just announced. A one day review- are you freaking kidding me!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

Q3: What criteria are used to determine who gets a CNPV?
A3: The Commissioner will establish national priorities such as, but not limited to:

Addressing a health crisis in the U.S.Bringing potential innovative therapies to the American people.Addressing unmet public health needs.Significantly increasing the national security of the U.Shttps://www.2firsts.com/news/fda-launches-national-priority-review-program-drugs-aligned-with-us-priorities-may-be-approved-in-as-little-as-one-month
According to the FDA, the new CNPV program introduces a team-based review approach. Rather than sending applications to multiple FDA offices for separate evaluations, the program assembles a multidisciplinary team of FDA physicians and scientists to pre-review submitted materials and then conduct a 1-day “tumor board style” meeting to evaluate the application collectively. This differs significantly from the agency’s traditional sequential review system.
To be eligible, sponsors must submit the chemistry, manufacturing, and controls (CMC) section of the application and draft labeling at least 60 days prior to final application submission. Sponsors must also be available for real-time communication and respond promptly to FDA inquiries during the CNPV review.

FDA has just approved Ryoncil's CMC and labelling. Dosing is per weight nothing to do with age. Adult EAP results were 73% survival.

FAQs: Commissioner’s National Priority Voucher Program

• Press Announcements
  
  
  
  

Q1: What’s the difference between the Commissioner’s National Priority Voucher (CNPV) and the existing Priority Review and Priority Review Voucher (PRV) programs?
A1: These are separate programs and not mutually exclusive. The existing priority review programs and PRV programs will continue as is. The CNPV program will begin in 2025 and contains some of the elements and themes of the priority review programs and PRV programs with a different timeline for the review, product designated and product undesignated subtypes, and prohibition on the sale of the voucher.

Q2: When will the new vouchers be given out?
A2: The FDA will give out these new vouchers in 2025. After a 1-year pilot phase, the agency may increase the number of CNPVs it gives to companies.

Q3: What criteria are used to determine who gets a CNPV?
A3: The Commissioner will establish national priorities such as, but not limited to:

• Addressing a health crisis in the U.S.
• Bringing potential innovative therapies to the American people.
• Addressing unmet public health needs.
• Significantly increasing the national security of the U.S.

Q4: Are CNPVs transferrable to another company?
A4: These vouchers are non-transferrable. However, they will remain valid through changes in company ownership.

Q5: Does the CNPV program affect pre-existing expedited review programs, such as fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation?
A5: No, the CNPV program will not affect other programs but will incorporate some of their elements.

Q6: Can the CNPV be applied to a product at any stage of FDA review?
A6: Yes, the voucher can be applied to a product at any stage in development. If granted during the investigational new drug phase of a drug, the company will receive the CNPV’s enhanced communication benefits. Interim reviews throughout the process will benefit from enhanced communication and prompt responses.

Q7. Do the CNPVs expire?
A7: Yes, the voucher must be used within two years following receipt from the FDA.

Q8: What type of drugs are candidates for the CNPV designation?
A8: The program can be applied to drugs in any area of medicine. The program does not currently apply to devices or combination drug-device applications.

Q9: How can a company apply for a CNPV?
A9: The agency will provide information in the near future on how companies seeking to apply can indicate their alignment with the FDA Commissioner’s criteria to meet national priorities.