Drugs

Bioresearch Monitoring Violations by Dr. Peter Michael

A 6/3-6/11/2024 FDA bioresearch monitoring inspection at a clinical site maintained by Dr. Peter Michael in Hialeah, FL, found that Michael did not adhere to the law and regulations governing the conduct of clinical investigations and protecting human subjects in two studies. A just-released 6/18 Warning Letter emphasized that Michael failed to ensure that the investigation was conducted according to the investigational plan.

The letter acknowledges the corrective and preventive actions the clinical site has taken, but says Michael’s response is inadequate because he did not include sufficient details on the training or procedures implemented to prevent similar violations in the future. The agency also says the response does not provide sufficient details about how Michael, as the clinical investigator, will ensure adequate oversight of study procedures.

“Given the significance of the protocol violation involving pediatric subjects, we request follow-up documentation regarding the training and procedures implemented at your site to ensure compliance with study protocol dosing procedures,” the letter says. “Without this information, we are unable to determine if your corrective action plan is adequate to prevent similar violations in the future.”

Michael 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