Independent Third-Party Assessment of Investigational New Drug Food and Drug Administration-Sponsor Communication Practices in Prescription Drug User Fee Act VI; Public Meeting; Request for Comments

الملخص

The Food and Drug Administration (FDA, the Agency, or we) is hosting a public meeting entitled "Independent Third-Party Assessment of IND FDA-Sponsor Communication Practices in PDUFA VI," and an opportunity for public comment. The meeting will include 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; a series of presentations by and a panel discussion with invited regulatory and industry representatives, and an open public comment period. This meeting is intended to satisfy FDA's commitment to host a public meeting about the assessment no later than March 2021.