BIO Comments on FDA Public Workshop on Patient-Focused Drug Development: Guidance 1
February 16, 2018
BIO submitted comments after the Food and Drug Administration’s (FDA) public hearings on Patient-Focused Drug Development: Guidance 1 – Collecting Comprehensive and Representative Input.
BIO commends the FDA’s efforts to facilitate the use of patient experience data (PED) for medical product development and regulatory decision-making. Flexibility and openness to innovative methods and practices will be important as new ideas and approaches emerge every day.
While BIO agrees the patient-focused drug development (PFDD) guidance documents should complement the FDA guidance on patient-reported outcomes (PRO), the PRO guidance is too restrictive and has not led to an increase in qualified or validated PRO tools for use in labeling. BIO asks FDA to keep the PFDD guidance documents broadly applicable and flexible. BIO’s comments include answers to the FDA’s questions and suggestions on how to clarify and improve the PFDD guidance.
Download Full Comments Below
BIO Letter Patient-Focused Drug Development Guidance 1 Collecting Comprehensive And Representative Input FDA2017-N-5896
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 after the Food and Drug Administration’s (FDA) public hearings on Patient-Focused Drug Development: Guidance 1 – Collecting Comprehensive and Representative Input.
BIO commends the FDA’s efforts to facilitate the use of patient experience data (PED) for medical product development and regulatory decision-making. Flexibility and openness to innovative methods and practices will be important as new ideas and approaches emerge every day.
While BIO agrees the patient-focused drug development (PFDD) guidance documents should complement the FDA guidance on patient-reported outcomes (PRO), the PRO guidance is too restrictive and has not led to an increase in qualified or validated PRO tools for use in labeling. BIO asks FDA to keep the PFDD guidance documents broadly applicable and flexible. BIO’s comments include answers to the FDA’s questions and suggestions on how to clarify and improve the PFDD guidance.