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Pharmaceuticals / Regulatory Affairs / Postmarket Safety

Drugmakers Call for More Flexible Templates for REMS

Dec. 19, 2017
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Parts of the FDA’s recently updated draft guidance on the content and formatting of REMS documents are overly prescriptive, stakeholders said in public comments to the agency.

The draft guidance, revised in October, expands the use of tables and bullet points, recommending separate tables for each type of participant in the program — such as healthcare providers, pharmacies, patients and wholesalers. It details the actions required by each and the REMS materials involved.

PhRMA said the guidance may not allow for necessary modifications, and suggested allowing leeway in using different terms to allow for a more nuanced approach.

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