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At the FDA’s request, U.S. marshals Sept. 5 seized a approximately $55,000 of dietary supplements for violating the Federal Food, Drug, and Cosmetic Act’s new drug and misbranding provisions.
Coming on the heels of an internal report critical of inaccuracies in the FDA’s drug data system, the agency is proposing a new rule requiring drug manufacturers to electronically register all their products — prescription or OTC — in an Electronic Drug Registration and Listing System (EDRLS).
Fresh off an internal report critical of inaccuracies in the FDA’s drug data system, the agency is proposing a new rule requiring drug manufacturers to electronically register all their products — prescription or OTC — in an Electronic Drug Registration and Listing System (EDRLS).
Federal prosecutors will be more aggressively enforcing anti-kickback laws for deals between industry sales reps and hospitals in Medicaid drug and device negotiations, a high-ranking Department of Justice (DOJ) official said.
The FDA and other regulatory agencies must step up to stem the tide of unscrupulous drug marketing practices, an article in the Annals of Internal Medicine says.
After winning a lawsuit against the FDA, Utah Medical Products is taking another step in its battle with the agency, filing a petition with HHS Aug. 8 saying the FDA should remove a two-year-old press release about the firm from its website.
The Biotechnology Industry Organization (BIO) is praising an Aug. 9 decision by the SEC to give smaller public companies additional time to comply with the internal control requirements under the Sarbanes-Oxley Act (SOX).
The patent settlement between sanofi-aventis, Bristol-Myers Squibb (BMS) and Apotex designed to prevent the sale of generic Plavix has been abandoned by all parties at the same time it became the focus of a federal antitrust investigation.
Having completed a draft document on clinical evaluation for medical devices, Study Group 5 (SG5) of the Global Harmonization Task Force (GHTF) announced plans to adapt the proposed document for in vitro diagnostic (IVD) devices.