BIO Submits Comments on FDA Draft Guidance on Format and Content of a Risk Evaluation and Mitigation Strategy Document
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Format and Content of a Risk Evaluation and Mitigation Strategy Document.
The draft guidance provides recommendations to applicants on drafting proposed Risk Evaluation and Mitigation Strategy (REMS) documents and converting an already-approved REMS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.