Drugs

‘Objectionable Conditions’ in Prodrome Sciences BIMO Inspection

A 12/17/2024-1/10/2025 FDA Bioresearch Monitoring Program inspection of the Temecula, CA, Prodrome Sciences USA clinical investigation of Omega-3 plasmalogens found objectionable conditions indicating that the company did not adhere to laws and regulations governing the conduct of clinical investigations and the protection of human subjects. A 1/8 Warning Letter says Prodrome failed to submit an IND for the conduct of a clinical investigation with an investigational new drug.

Although the company’s response to the investigation observations indicated that the trial involved a dietary supplement, FDA says, the evidence collected during the inspection indicated that the product being studied was intended for use as a drug and not a dietary supplement.

FDA acknowledges the firm’s submission of a corrective and preventive action plan, but says the submission was inadequate in that it did not contain sufficient details on several issues, including how Prodrome will determine if IND regulations will apply to future investigations and the development and implementation of procedures to comply with IND regulations.

Prodrome Sciences 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