FDA Policy/General

FDA Denies Petition on Probiotic Suppositories as Supplements

FDA has denied a ProbioTech petition filed in April that asked the agency to change the definition of a dietary supplement under the Dietary Supplement Health and Education Act and to treat probiotic suppositories the same as oral probiotic dietary supplements. The petition says that probiotics that are not in the form of a pill, capsule, tablet, or liquid and do not fit into the definition of a drug, device, or biologic should be considered a dietary supplement if they function essentially the same and do not come in the form of a pill, capsule, tablet, or liquid. “ProbioTech seeks to market a probiotic delivered by a rectal suppository, which should not be deemed a new drug as there is no claim to diagnose, cure, mitigate, treat, or prevent a disease,” it said. “The product should not be put through the onerous submission and approval process for a new drug substance.”

In denying the petition, FDA said that a request to amend the Food Drug & Cosmetic Act is not an action that can be the subject of a citizen petition. Additionally, FDA said that the definition of a dietary supplement limits qualified products as those intended for ingestion. “FDA may not ignore this statutory constraint and classify suppositories as dietary supplements,” it said.

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