Placeholder Banner

BIO Comments on FDA Draft Guidance on Formal Meetings Between the FDA and Sponsors or Applicants of Prescription Drug User Fee Act Products

March 27, 2018

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products.

The Prescription Drug User Fee Act (PDUFA) meeting structure fosters robust communication between the FDA and industry and promotes biomedical innovation. Formal, face-to-face meetings – along with other types of communication like well-written responses, phone calls, and emails – are critical for aligning on complex scientific matters throughout the drug development process.

With clarifications, this guidance could be a helpful tool for sponsors to engage in more productive discussions with the FDA. BIO requests clarifications on surrogate endpoint/biomarker Type C meetings, background package contents, whether FDA welcomes discussion of emerging data sources (patient experience data, novel trial designs, real-world evidence), preliminary responses to sponsors, and meeting timelines, among other issues.  

Download Full Comments Below
BIO Letter Formal Meetings Between The Food And Drug Administration And Sponsors FDA–2017-D-6530
Read full comment letter below
Discover More
September 22, 2020 Re: Docket No. FDA-2019-N-5553: Annual Summary Reporting Requirements Under the Right to Try Act, Proposed Rule Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or…
September 27, 2020 Re: Docket No. FDA-2014-D-1551:  FDA Draft Guidance, Pregnancy, Lactation, and Reproductive Potential:  Labeling for Human Prescription Drug and Biological Products – Content and Format. Dear Sir/Madam: The…