BIO Comments on FDA Draft Guidance on How to Prepare a Pre-Request for Designation (Pre-RFD)
April 13, 2017
BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, How to Prepare a Pre-Request for Designation (Pre-RFD).
BIO supports continued improvements to the review process of combination products. BIO says the draft guidance promotes early dialogue between sponsors seeking approval of combination products and the FDA. BIO provides additional suggestions to help clarify the draft guidance.
Dear Congressional Leaders:On behalf of the Council of State Bioscience Associations (CSBA)—a national coalition of independent, state and territory-based organizations representing the full breadth of America’s biotechnology ecosystem—we write to…
Re: Docket No. CDC-2025-0783; Advisory Committee on Immunization Practices (ACIP) MeetingDear Dr. Zadeh and Members of the ACIP:The Biotechnology Innovation Organization (BIO) appreciates the opportunity to provide comments to the Advisory Committee…
Chairman Cassidy, Ranking Member Sanders, and distinguished Members of the Committee:Thank you for the opportunity to appear before you today on behalf of the Biotechnology Innovation Organization (BIO), which represents more than 1,000…
BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, How to Prepare a Pre-Request for Designation (Pre-RFD).
BIO supports continued improvements to the review process of combination products. BIO says the draft guidance promotes early dialogue between sponsors seeking approval of combination products and the FDA. BIO provides additional suggestions to help clarify the draft guidance.