Drugs

Drug QA Inspections Up 40%: Report

The FDA FY 2023 Office of Pharmaceutical Quality (OPQ) annual report says there were 776 drug quality assurance inspections, over 40% more than the 548 in FY 2022. In addition, it says, there were 187 mutual recognition agreement partner inspections, the highest number achieved to date.

At the end of FY 2023, the report says, the CDER site catalog included 4,819 drug manufacturing sites, a 14% increase in the number of sites over the past five years.

OPQ says the 93 drug quality-related import alert additions in FY 2023 were more than the 77 in FY 2021 and FY 2022 combined. Some 17% of recalled products were associated with ophthalmic drug products, OPQ says. The number of recalls was 26% less than in FY2022 but similar to the five-year age.

The report’s Introduction says that in addition to analyses and insights about drug manufacturers and their products, the report:

highlights two quality surveillance programs that are advancing CDER’s quality oversight;
describes new approaches to help FDA and its stakeholders better prevent or mitigate quality issues that may lead to supply chain vulnerability and drug shortages in a changing environment;
presents reasons for new drug shortages that occurred in calendar years 2022 and 2023;
provides data on recalls and global trends in quality and product failures; and
shares findings from a recent assessment of the public health value of requests for records and other information under the Federal Food, Drug, and Cosmetics Act.

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