BIO Submits Comments on FDA Draft Guidance on Format and Content of a Risk Evaluation and Mitigation Strategy Document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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Format and Content of a Risk Evaluation and Mitigation Strategy Document.
The draft guidance provides recommendations to applicants on drafting proposed Risk Evaluation and Mitigation Strategy (REMS) documents and converting an already-approved REMS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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Format and Content of a Risk Evaluation and Mitigation Strategy Document.
The draft guidance provides recommendations to applicants on drafting proposed Risk Evaluation and Mitigation Strategy (REMS) documents and converting an already-approved REMS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