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HHS Secretary Tommy Thompson yesterday sidestepped a question about whether FDA Commissioner Mark McClellan would soon be appointed head of the Centers for Medicare & Medicaid Services (CMS).
The FDA has recommended that manufacturers adopt electronic track-and-trace technology by 2007 as well as multiple authentication technologies in order to combat the distribution of counterfeit drugs, according to the final report of the agency's Counterfeit Drug Task Force released yesterday.
OTC drugmaker Almil Nutritional Products has been issued an FDA warning letter outlining 12 good manufacturing practice (GMP) deficiencies found by investigators during an inspection of its Brea, Calif., manufacturing facility.
FDA Commissioner Mark McClellan has asked Canadian authorities to more aggressively regulate internet pharmacies in the wake of a Minnesota study that found safety violations at several sites.
The FDA has delayed issuing a decision on whether to approve OTC status for the emergency contraceptive Plan B (synthetic progestin levonorgestrel) so that it can review additional data submitted by Barr Pharmaceuticals and the Women’s Capital Corporation (WCC).
The Center for Drug Evaluation and Research (CDER) has updated mailing addresses for a variety of biological therapeutic product submissions, the center announced Feb. 13.
PhRMA believes time limitations defined in an FDA draft guidance on dispute resolution (DR) would place manufacturers at a disadvantage when using the system or result in dispute resolution requests that are incomplete.
Washington, D.C.-based law firm Hogan & Hartson has joined a growing number of petitioners urging the FDA to allow over-the-counter (OTC) hearing aid sales.