Drugs

Drug Inspections at ‘Operational Levels’: Throckmorton

CDER deputy director for regulatory programs Douglas Throckmorton told the GMP by the Sea conference that domestic drug inspections of facilities have been at “standard operational levels” since 10/2021 and foreign inspections have been performed for six months, except in China. Attorney Douglas Farquhar (Hyman, Phelps & McNamara) reports in his firm’s FDA Law Blog that Throckmorton also said the number of required pre-approval inspections has been cut by about 50% as a result of FDA reexamining the necessity of so many pre-approval inspections.

Throckmorton reportedly told the conference that many of the operational changes made due to Covid will become permanent. “The agency has reexamined whether, from a risk perspective, so many on-site inspections are necessary, either because the risk of problems at a particular facility is low, or because alternatives (such as records inspections or what FDA refers to as ‘remote interactive evaluations’) can substitute for on-site inspections,” Farquhar writes.

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