Drugs

FDA Denies Probiotic Suppository Petition

FDA has denied a 4/7/16 ProbioTech petition asking the agency to amend the definition of “dietary supplement” under the Dietary Supplement Health and Education Act of 1994 so that probiotic suppositories could be treated the same as oral probiotic dietary supplements. The company said that if the definition is not changed, FDA should allow a supplemental probiotic that is inserted as a rectal suppository to be classified as a dietary supplement as another delivery route in addition to the oral route.

The agency’s denial letter says the definition in the Federal Food, Drug, and Cosmetic Act (FFDCA) indicates that ingestion is the only permissible route of administration for dietary supplements. It notes that a request to amend the act is not an action that can be the subject of a citizen petition and the agency does not have the authority to amend a statutory definition. It also denied the alternative request to consider a suppository as another delivery route because FDA cannot take administrative action that conflicts with the FFDCA.

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