REMS format and content: FDA offers draft guidance

On October 11, FDA released updated draft guidance for the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drugs and biologics.

On October 11, FDA released updated draft guidance for the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drugs and biologics. The 34-page draft, which revises 2009 draft guidance, removes information related to REMS assessments and proposed REMS modifications that are being addressed in separate guidance documents. The draft is meant to help ensure REMS documents are clear, understandable, and to the extent possible, consistent in content and format. FDA also released draft guidance providing recommendations for industry on the procedures for resolving scientific and/or regulatory issues between FDA and applicants of abbreviated new drug applications (ANDAs). FDA said the draft provides information for ANDA applicants to consider before pursuing a request for reconsideration, procedures for submitting a request for reconsideration, and the process for responding to a request.