Drugs

CHPA Recommendations for Implementation of Genus Decision

The Consumer Healthcare Products Association (CHPA) says there are several steps FDA should take as it implements the DC Court of Appeals decision in Genus Medical Technologies. The court determined that FDA cannot regulate as a drug any product that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act.

Responding to an agency request for comment on its approach to implementing the decision and the categories of products involved, CHPA says FDA should:

specify how it will implement device classification into Class 1, 2, or 3 for products currently regulated as drugs that are transitioned to device status due to Genus;
determine the least burdensome manner for transitioning products from drug to device and allow sufficient time for the transition, recognizing that sponsors will need time to transition from one regulatory scheme to another;
give additional details on the process for requesting a user fee refund due to transition and how those requests will be handled; and
apply the principles of Genus in determining whether the constituent parts of a combination product are drug or device constituents.

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