Drugs

45% of CDER Warning Letters Cited GMPs: Report

CDER says that the majority (45%) of drug Warning Letters issued in fiscal year 2023 cited GMP requirement violations. The next highest category of letters issued (22%) was for misbranding/unapproved drug product violations, according to a just-released Office of Compliance FY 2023 Annual Report. Compared to last year, the Center saw an increase in Warning Letters citing a failure to respond to FDA-issued requests for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The report notes that the most common GMP citation last year in Warning Letters to drug manufacturing facilitites involved quality units (21 CFR 211.22). This was followed by control and testing citations (21 CFR 211.84), written procedures and deviations (21 CFR 211.100), production record review (21 CFR 211.192), and equipment cleaning and maintenance (21 CFR 211.67(b)).

CDER says the majority of drug GMP or adulteration Warning Lletters were issued after an on-site inspection, either a facility’s first inspection or a reinspection, adding that 28% of these resulted from findings documented under FDA’s remote oversight tools.

Additionally, the report says the Center classified 264 recall events totaling 1,178 violative drug products, including 28 events that were potentially life-threatening. The top three reasons for recall were GMP deviations, lack of assurance of sterility and failed impurities/degradation specifications.

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