Drugs

Determine NMN is a Dietary Supplement: Petition

The Natural Products Association and the Alliance for Natural Health have petitioned FDA to determine that nicotinamide mononucleotide (NMN) is not excluded from the definition of a dietary supplement. A statement from the two associations (contains a link to the citizen petition) says the groups also want the agency to:

commit to exercising enforcement discretion in connection with the NMN in or as a dietary supplement; or
in the alternative, recommend the HHS secretary issue a regulation after notice and comment finding NMN would be lawful.

“The agency’s reversal on MNM NDIs is without statutory authority,” the statement says…. “Our system is broken. FDA is allowing pharmaceutical companies to ransack nature by monopolizing nutrients that can and should be dietary supplements. NMN is found in foods like broccoli, avocado, and cucumbers. This life-extending substance should be widely available, but FDA is creating a situation in which only those who can afford to pay exorbitant drug prices will be able to enjoy NMN’s many benefits.”

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