The FDA did not attend a House Energy and Commerce subcommittee hearing Tuesday focused on why the agency has stalled out on its pre-pandemic efforts to improve inspections of overseas manufacturers that supply drugs to the U.S. Read More

Lapses in digital security, missed report deadlines, and a complete lack of quality oversight earned manufacturers some notable 483s. And here’s a first: How about getting written up for being too clean? Read More

The FDA has revised a previous draft on its current approach to conducting remote regulatory assessments (RRA), incorporating public comments as well as recent amendments to the Food, Drug and Cosmetic Act. Read More

The FDA has warned Novartis that its direct to consumer TV ad for its breast cancer drug Kisqali (ribociclib) makes false or misleading representations about the drug’s efficacy, sending the company an untitled letter. Read More

Inspections will be much more streamlined once the FDA completes its sweeping reorganization, according to Deputy Commissioner Janet Woodcock. Read More

A litany of failures spanning inadequate personnel, manufacturing, cleaning and other lapses have resulted in the FDA serving a Form 483 to Advanced Cosmetic Research Laboratories (ACRL) following the agency’s July 2023 inspection of the Chatsworth, Calif., facility. Read More

In its continuing effort to step up post-pandemic enforcement activities, the FDA wrapped up 2023 by making public three Form 483s for as many Indian pharmaceutical manufacturers. Read More

Drug containers contaminated with wood, cellulose, brass and steel as well as multiple corrective and preventive actions (CAPA) to address mold are among the reasons the FDA listed in its untitled letter to Novartis Pharmaceuticals over its biological product Kymriah (tisagenlecleucel). Read More

In 2022, FDA inspections of both foreign and domestic drug manufacturing plants were still far below pre-COVID-19 pandemic levels, although the number of citations soared, a new study has found. Read More