Drugs

Lilly Inspection Cites 8 Findings: Report

A 7/2023 inspection of Eli Lilly’s Branchburg, NJ cited eight GMP deficiencies, which included problems in overseeing manufacturing process and quality controls, equipment calibration, and maintaining facilities and equipment, according to inspection documents referenced in a Reuters report. The inspection was in response to a manufacturing change request from Lilly involving its migraine treatment Emgality, the company told the news service.

Reuters shared the inspection report it received under the Freedom of Information Act with three regulatory experts who characterized the findings as “serious.” One expert, former CDER Office of Manufacturing and Product Quality director Steven Lynn had this to say: “It’s like whack-a-mole at this plant. The company seems to address one set of problems, only for other serious concerns to keep popping up.”

The manufacturing facility was cited in 2022 when the agency inspected Lilly’s Imclone Systems unit (see earlier story). FDA released the form FDA-483 with two inspection observations:

failing to control the disposition and availability of drug substances determined to be within the scope of deviation investigations before the satisfactory completion of evaluation by the quality unit; and
failing to adequately document, explain, and investigate all deviations from established laboratory procedures.

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