REMS Format and Content: FDA Offers Draft Guidance

Posted 11 October 2017 By Zachary Brennan

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The US Food and Drug Administration (FDA) on Wednesday released updated recommendations in the form of a draft guidance for the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drugs and biologics.

The 34-page draft revises 2009 draft guidance for industry known as, "Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications." FDA notes at the outset that the updated recommendations on the format and content of a REMS document, which establishes the goals and requirements of a REMS, removes information related to REMS assessments and proposed REMS modifications that are being addressed in separate guidance documents.

This draft -- meant to help ensure REMS documents are clear, understandable, and to the extent possible, consistent in content and format -- offers an overview of the types of information that should be included in a REMS document and further details in a template appended to the guidance.

"This guidance does not provide detailed information on the format and content of other documents that are part of a REMS submission, such as the REMS materials or the REMS supporting document. Furthermore, the guidance does not include information on how to design, implement, or evaluate a REMS, and does not address submissions that are unique to shared system REMS," FDA said.

FDA also said it does not expect applicants of an approved product subject to a REMS to submit a proposed REMS modification solely to convert their REMS document to the new format.

Requests for Reconsideration

Also on Wednesday, FDA released draft guidance providing recommendations for industry on the procedures for resolving scientific and/or regulatory issues between FDA and applicants of abbreviated new drug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).

As agreed to by FDA and industry in the latest GDUFA reauthorization from 2018-2022, an ANDA applicant "may pursue a request for reconsideration within the review discipline at the Division level or original signatory authority, as needed."

The GDUFA II commitment letter also states that FDA's Office of Generic Drugs' Office of Regulatory Operations Associate Director will track each request from division level reconsideration through resolution.

Though at the conclusion of a request for reconsideration, an applicant may pursue formal dispute resolution above the division level.

FDA also noted that it agreed to certain review goals and procedures for requests for reconsideration of the classification of the standard review status of an ANDA, ANDA amendment, prior approval supplement (PAS), or PAS amendment (i.e., that the regulatory submission is subject to a 10-month standard review and not an 8-month priority review).

"Specifically, the Agency agreed that if an applicant requests a teleconference as part of its request to reclassify: (1) a major amendment to an ANDA or a PAS, or (2) the standard review status of an ANDA, ANDA amendment, PAS, or PAS amendment, ‘FDA will schedule and conduct the teleconference and decide 90% of such reclassification requests within 30 days of the date of FDA's receipt of the request for a teleconference. This [30-day] goal only applies when [the] applicant accepts the first scheduled teleconference date offered by FDA,'" the draft said.

FDA noted that this 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.

Format and Content of a REMS Document: Draft Guidance for Industry

Requests for Reconsideration at the Division Level Under GDUFA: Draft Guidance for Industry

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Categories: Drugs, Labeling, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: REMS, REMS document, FDA draft guidance, GDUFA II

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