Placeholder Banner

BIO Submits Comments on FDA Draft Guidance on Format and Content of a Risk Evaluation and Mitigation Strategy Document

December 11, 2017

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Format and Content of a Risk Evaluation and Mitigation Strategy Document.

The draft guidance provides recommendations to applicants on drafting proposed Risk Evaluation and Mitigation Strategy (REMS) documents and converting an already-approved REMS document to a new standardized format.

BIO provides suggestions for how to improve the guidance regarding REMS requirements for programs run or administered through specialty pharmacy healthcare settings. In addition, BIO asks the FDA to specify details on storage and retention of participant documents, monitoring of patients, and the duration of retention of participant materials.

Download Full Comments Below
FINAL BIO Letter Format And Content REMS
Read full comment letter below
Discover More
On November 9, BIO submitted comments on the FDA Draft Guidance, Drug-Drug Interaction Assessment for Therapeutic Proteins. In the comments, BIO thanks the FDA for the opportunity to submit comments but requests that the Guidance include a…
On August 6, BIO submitted comments on the NMPA Draft Technical Guideline on Clinical Trials of Cellular Immunotherapy Products. In the comments, BIO thanks NMPA for the opportunity to submit comments but argues for a more robust commenting period…
October 30, 2020 Re: Docket No. FDA–2020-D-1564: FDA Draft Guidance, Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. Dear Sir/Madam: The Biotechnology…