Drugs

Draft REMS Document Format Guidance Out

FDA has issued a draft guidance, Format and Content of a REMS Document, with updated recommendations for the format and content of a risk evaluation and mitigation strategy (REMS) document for a prescription drug product, including biological products. The document provides recommendations to applicants on drafting proposed REMS documents and converting an already-approved REMS document to a new standardized format that is clearer, more informative, and supports submission of a REMS document in Structured Product Labeling format.

FDA says 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. Rather, it says, changing the REMS document to the new format should be done in conjunction with other REMS modifications.

The guidance revises a 2009 draft guidance to (1) provide updated recommendations on the format and content of a REMS document, and (2) remove information related to REMS assessments and proposed REMS modifications that are being addressed in separate guidance documents.

Major topics included in the document are Introduction, Background, Format and Content of a REMS document, and Procedures, with a REMS document template as an appendix.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome