BIO Comments on FDA Draft Guidance on Patient-Focused Drug Development: Collecting Comprehensive and Representative Input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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.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 BIO sees this first draft guidance, addressing comprehensive and representative input, as an important tool for strengthening our collective understanding of the evidence needed to support the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
The Biotechnology Innovation Organization appreciates the opportunity to comment on the Center for Medicare and Medicaid Services’ Information Collection Request on the Part C and Part D Medicare Prescription Payment Plan Model Documents.
In response to their advance notice of proposed rulemaking (ANPRM), BIO submitted comments to the DOJ's National Security Division on implementing the White House Executive Order of February 28, 2024, “Preventing Access to Americans’ Bulk Sensitive…
We, the undersigned, are writing to express our strong concern with a proposed update to the Medicaid Drug Rebate Program. If finalized in its current form, the proposed rule (CMS-2434-P) would impose significant costs to the government and industry…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.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 BIO sees this first draft guidance, addressing comprehensive and representative input, as an important tool for strengthening our collective understanding of the evidence needed to support the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.