Drugs

‘Objectionable Conditions’ in Children’s Hospital Trials

A 9/23-10/12/23 FDA Bioresearch Monitoring Program inspection of two clinical trials led by Dr. Jeffrey Taub at Children’s Hospital of Michigan found “objectionable conditions,” according to a just-released 12/19/23 Warning Letter. The letter says it appears that Taub did not adhere to the applicable legal requirements governing the conduct of clinical investigations and the protection of human subjects. It says specific concerns were:

failing to ensure that the investigation was conducted according to the investigational plan; and
failing to ensure that an institutional review board that complies with regulatory requirements was responsible for the initial and continuing review and approval of the proposed clinical study.

The letter says FDA acknowledges the corrective and preventive actions that the clinical trial site has taken, but Taub’s responses to the inspection observations were inadequate due to a lack of sufficient details.

He was told to respond with a list of specific steps that have been 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