Drugs

REMS Modification, Revision Guidance

FDA has published a guidance, Risk Evaluation and Mitigation Strategies: Modifications and Revisions, with information on how the agency defines the types of changes to an approved risk evaluation and mitigation strategy (REMS), how application holders should submit changes to an approved REMS, and how FDA will process submissions from application holders for changes to REMS. The document provides specific information on what types of changes to REMS will be considered modifications of the REMS, and what types of changes will be considered revisions of the REMS (changes that may be implemented following notification of FDA).

The guidance applies to all types of REMS, including those that are part of a shared system. It does not address additional submission procedures that may apply to application holders proposing changes to REMS that are part of a shared system and that use a drug master file for their REMS submissions.

Contents of the guidance are Introduction, Background, Policy, Submission Procedures, FDA Time Frames for REMS Changes, Contact Information, and an Appendix.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

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