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The FDA has cleared a roadblock to generic competition against King Pharmaceuticals’ muscle relaxant Skelaxin (metaxalone) by not requiring generic firms to list some prescribing information on the label.
The FDA is likely to update an 8-year-old draft guidance on weight loss drugs to address newer long-term therapies and to advance an HHS campaign to alleviate the obesity epidemic in the U.S., the agency said on Friday.
Nearly two-thirds of open postmarketing study commitments drugmakers made to FDA after the agency approved their new drug applications (NDAs) or abbreviated new drug applications (ANDAs) have yet to begin, the agency said in an annual report released on Friday.
The FDA has issued a warning letter to Dublin, Calif.-based Obsidian Medical Technology for allegedly violating numerous good manufacturing practice requirements of the quality system regulation (QSR).
The FDA has accused a University of Chicago clinical trial investigator of implanting an unapproved cardiac device in at least eight patients during the last three years.
Devicemakers should consider risk management over the total product life cycle using a top-down approach, FDA staffers and industry experts said last week at the Association for the Advancement of Medical Instrumentation/FDA international conference on medical device standards and regulations.
Devicemakers will soon have a revised set of internationally harmonized codes for reporting adverse events, which will focus more heavily on cause types, according to Carol Herman, the standards director at the Center for Devices and Radiological Health.
The percentage of warning letters issued by the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) for misleading ad practices jumped dramatically in 2003 compared to the percentage issued by the division in previous years, indicating a shift toward a tougher enforcement strategy.
Applications are still being accepted by several Center for Drug Evaluation and Research (CDER) product review divisions for a pilot program to assess the effectiveness of continuous marketing applications for fast-track designated drugs, the agency announced last week.