Drugs

Bioresearch Monitoring Issues in Mazhar Trials

A 3/22-4/28/22 FDA inspection of three clinical trials conducted by Dr. Mobeen Mazhar in Houston, TX, undertaken as part of the agency’s bioresearch monitoring program, identified objectionable conditions. A 5/31 Warning Letter says it appears that Mazhar did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act and applicable regulations governing the conduct of clinical investigations and the protection of human subjects. The letter says specific violations were:

failing to ensure that the investigation was conducted according to the investigational plan; and
failing to obtain informed consent following the regulations.

“While we acknowledge that you closed all clinical studies at your site,” the letter says, “you have not provided details about how you plan to prevent similar violations from occurring if you decide to participate as a clinical investigator in a future clinical investigation.”

Mazhar was told to respond with a list of specific actions he 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