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BIO Submits Comments on Draft PDUFA Meetings Guidance

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The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the revised draft guidance for industry entitled &ldquo;Formal Meetings Between the FDA and Sponsors or Applicants of Prescription Drug User Fee Act (PDUFA) Products.&rdquo;</p>

BIO commends FDA on the revised Draft Guidance, as it will provide additional clarity for Sponsors requiring formal meetings with the Agency. BIO believes that effective communication between the Sponsor and FDA can help to expedite drug development, and that clear guidance on when a specific type of meeting is appropriate creates a more predictable and transparent drug development and review process.