Updates to Commissioner's National Priority Voucher Frequently Asked Questions

I had not noticed this previously but the FDA has updated the Commissioner's National Priority Voucher Frequently Asked Questions in December and again a few days ago to add pre-submission requirements to the requirements. This was implemented following early learnings of the program:

• Q: What are the pre-submission requirements and recommendations for new applicants to the CNPV Program?
• A: Based on early experience in the pilot, FDA is enhancing pre-submission requirements for any new CNPV voucher recipients as noted below. In general, we would request that sponsors submit any available data to FDA as soon as possible, prior to the submission of the complete application.At least 60 days before the complete application is submitted, or at least 120 days before if foreign inspections will be needed:
  
  • Required: Submit CMC data, draft labeling
  • Required: Specify manufacturing facilities and BIMO BA/BE study sites (clinical/analytical/in vitro)
  • Required: Submit relevant information regarding devices for combination products (e.g., manufacturing, human factors, risk assessments)
  • Recommended: List no more than 2-3 manufacturing facilities, provide a justification for additional sites
  • Recommended: Submit all available data relating to the application (e.g., raw data, toxicology, non-clinical data, clinical/safety data, application components that are complete)
  • Recommended:  As applicable, submit the items described in the FDA guidance "Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry | FDA" to facilitate clinical investigator, sponsor, and contract research organization inspection planning. This information is requested for all major (i.e., pivotal) trials used to support safety and efficacy in the application.

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Source: FAQs: Commissioner’s National Priority Voucher Pilot Program