Drugs

No IND for American Behavioral Study: FDA

FDA says a 4/17-5/3/2024 Bioresearch Monitoring Program inspection at American Behavioral Research Institute (ABRI) in Boca Raton, FL, found that the institute failed to submit an IND for a study evaluating the effects of Relaxium in subjects with sleep disorder. A just-released 4/30 Warning Letter says that information gathered during the inspection determined that Relaxium was intended for use as a drug rather than a dietary supplement for the clinical investigation.

The letter says ABRI responded to the inspection observation that because it is in the business of marketing and distributing dietary supplements and not performing clinical studies, there is no risk of future violations because there is no chance of future studies. “We acknowledge your statement,” FDA says. “However, ABRI’s written response does not provide sufficient details of a corrective and preventive action plan for developing and implementing procedures to comply with IND regulations, should ABRI decide in the future to initiate another clinical investigation for which an IND is required. As a result, ABRI’s response is inadequate. Without this information, we are unable to determine whether ABRI will comply with the IND regulations in the future.”

ABRI was told to respond with a list of specific actions it has taken to prevent similar violations in the future.

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