Drugs

CDER OPQ to Continue Some Remote Assessments

The CDER Office of Pharmaceutical Quality (OPQ) 2022 annual report says FDA will continue to use remote regulatory assessments to augment on-site inspection activities. When Covid-19 restricted travel, the report says, OPQ turned to alternative tools such as requesting information from a facility instead of an inspection. “In 2022, OPQ staff conducted 65 pre-license facility inspections in 18 countries and 10 states and used remote regulatory assessments to act on 85 regulatory submissions, the report says.

The report notes that recent scientific innovations have resulted in advanced manufacturing technologies that can produce drugs in more expedient and flexible ways. OPQ says it leads FDA’s emerging technology program that gives stakeholders a venue to discuss and resolve potential technical and regulatory issues related to new technologies before filing regulatory submissions.

The report provides accomplishments under each of OPQ’s four strategic priorities — collaboration, innovation, engagement, and communication.

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