Drugs

Questions on Emergency-Use Injector Guidance

The Association for Accessible Medicines and Teva have raised identical questions and issues about an FDA draft guidance on technical considerations for demonstrating the reliability of emergency-use injectors submitted under a BLA, NDA, or ANDA. The company and association raise these issues:

FDA needs to come to a reasonable definition of “emergency-use” because the testing the agency describes in the guidance is rigorous and challenging and likely would not be appropriate for some, if not most, products;
the possibility that FDA would create a different standard for devices considered under an ANDA than the agency used in reviewing devices when they were originally approved under an NDA;
the arduous nature of the testing described in the guidance could discourage sponsors from innovating and updating device design attributes; and
the need for FDA to align the occurrence of a device failure with the possibility that harm will be experienced by the device user or patient as a result of the failure.

The two letters also contained technical line-by-line comments. Pfizer submitted a chart with only technical comments.

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