Drugs

Indefinite Delay for ‘Intended Use’ Rule

FDA says it is delaying indefinitely the effective date of amendments to the existing medical product “intended use” regulations to give the agency more time to consider comments on the proposal. A Federal Register notice scheduled to be published 3/16 says the action does not delay the effective date of the portions of the 1/9/17 final rule that describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, medical device, or combination product.

The portion of the final rule that is being delayed enunciated revised criteria using “totality of the evidence” to determine a product’s use. That change drew significant stakeholder comment. The notice says that many of the comments opposed what they described as a broadening from the 9/25/15 proposed rule of the types of evidence that could be considered in determining intended use, and specifically raised concerns with the “totality of the evidence” language included in the final rule.

“The wide-ranging proposals and recommendations for how FDA should address issues related to intended use … underscore the complexities of the issues involved,” FDA says in the notice. “We believe these comments provide additional support for the delay of the effective date of amendments to the existing medical product ‘intended use’ regulations. The agency needs more time to consider the feedback we received, make sure that our approach is guided by our public health mandate, and ensure the clarity of our rules on the subject.”

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