Drugs

Homeopathic Drugs Not ‘New Drugs’: Trade Group

Americans for Homeopathic Choice and three of its top leaders are challenging an FDA draft guidance on homeopathy that says it intends to treat all homeopathic medicines as if they are “new drugs.” In a citizen petition, the group says it believes that homeopathic medicines fall under the 1938 definition of “drug,” and that the law does not require premarket approval of homeopathic medicines already existing in the Homeopathic Pharmacopeia of the United States because they are not “new drugs.”

The petition asks FDA to:

establish an expert advisory committee on homeopathy;
convert language supplied by the group into a regulation;
simultaneous with review of the supplied regulation, withdraw the current pending guidance document “Drug Products Labeled as Homeopathic” issued 12/20/17;
during the time that FDA considers whether to publish a proposed regulation and until such time as the petition is resolved, the agency continue to use the submitted language as the guiding document for homeopathy; and
hold a public hearing on the matter before approving the 12/2017 guidance if it fails to grant the petition.

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