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The Food and Drug Administration is hosting a public meeting entitled “Independent Third-Party Assessment of IND FDA-Sponsor Communication Practices in PDUFA VI.”

As part of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2018 through 2022, FDA committed to contracting with an independent third party to assess FDA-sponsor communication practices during the Investigational New Drug (IND) stage of new drug/biologic development. The purpose of the assessment was to characterize current communication practices and identify good practices, challenges, and suggestions for improvement. 

The meeting will include (1) a presentation from an independent third-party contractor about its assessment of FDA-sponsor communications during the Investigational New Drug (IND) stage of drug/biologic development in the Prescription Drug User Fee Act (PDUFA) VI; (2) a series of presentations by and a panel discussion with invited regulatory and industry representatives, and (3) an open public comment period. Registrants will receive more information on how to provide comments prior to the meeting.

This meeting is intended to satisfy FDA’s commitment to host a public meeting about the assessment no later than March 2021 (pg. 21 of the PDUFA VI commitment letter). 

• Agenda (PDF)
• Federal Register Notice
• Meeting Recording

Resources for You

• PDUFA VI: Assessment of FDA-Sponsor Communication Practices During the IND Stage of Drug/Biologic Development

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