BIO Comments on FDA Draft Guidance on Patient-Focused Drug Development: Collecting Comprehensive and Representative Input
September 11, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.
In the comments, BIO applauds the FDA’s initiative to advance the use of patient-experience data (PED) to inform drug development and regulatory review. BIO sees this first draft guidance, addressing comprehensive and representative input, as an important tool for strengthening our collective understanding of the evidence needed to support the FDA regulatory process with PED.
BIO says the guidance presents standards that adhere to established standards for good research practice and provides enough information to gain insight into what is needed to compose an appropriate research study, but BIO strongly believes future guidance documents should emphasize the FDA’s willingness to exercise regulatory flexibility and acceptance of innovative designs and approaches for collecting PED. BIO’s comments provide suggestions for changes to the guidance to encourage broader adoption of PED.
Download Full Comments Below
BIO Letter Collecting Comprehensive And Representative Input FDA 2018-D-1893
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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.
In the comments, BIO applauds the FDA’s initiative to advance the use of patient-experience data (PED) to inform drug development and regulatory review. BIO sees this first draft guidance, addressing comprehensive and representative input, as an important tool for strengthening our collective understanding of the evidence needed to support the FDA regulatory process with PED.
BIO says the guidance presents standards that adhere to established standards for good research practice and provides enough information to gain insight into what is needed to compose an appropriate research study, but BIO strongly believes future guidance documents should emphasize the FDA’s willingness to exercise regulatory flexibility and acceptance of innovative designs and approaches for collecting PED. BIO’s comments provide suggestions for changes to the guidance to encourage broader adoption of PED.