Drugs

‘Objectionable Conditions’ at Hospital IRB

An FDA 11/2-11/8/2023 Bioresearch Monitoring Program inspection at the Armstrong County Memorial Hospital Institutional Review Board (IRB) in Kittanning, PA., found “objectionable conditions” indicating that the IRB did not adhere to applicable statutory requirements on the protection of human subjects. A 10/29 Warning Letter emphasized these findings that the IRB:

failed to prepare, maintain, and follow written procedures governing the functions and operations of the IRB; and
failed to prepare and maintain adequate documentation of IRB activities, including minutes of IRB meetings; and

The IRB was told to respond with a list of specific actions it has taken or plans to take to address violations and prevent their recurrence. The letter cautions that failure to address the matter adequately could lead to regulatory action.

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