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President Bush’s announcement on Feb. 20 to tap FDA Commissioner Mark McClellan for the top position of the Centers for Medicare & Medicaid Services (CMS) has triggered a shuffling of leadership roles at the FDA.
Barr Pharmaceuticals will have to wait until May to get an FDA decision on whether the firm’s emergency contraceptive Plan B (synthetic progestin levonorgestrel) will receive OTC status.
The debate over FDA user fees for generic firms has remained dormant in recent years, but that doesn’t mean the idea might not come back again, according to one agency official.
The Generic Pharmaceutical Association (GPhA) is questioning whether the FDA can find the additional time and personnel needed to comprehensively review additional in vivo bioequivalency (BE) data required of generic drugmakers under a proposed rule.
The FDA's Counterfeit Drug Task Force is urging drugmakers to adopt electronic track-and-trace technology by 2007, as well as multiple authentication technologies, in order to combat the distribution of counterfeit drugs.
While supporting the FDA’s goal of combating fake drugs, generic manufacturers say counterfeiters are unlikely to target their products because they are inexpensive and generate thin profit margins.
Bristol-Myers Squibb (BMS) has started running corrective ads for its leading cholesterol drug following FDA allegations last summer that the firm ran misleading direct-to-consumer (DTC) ads.
Savient Pharmaceuticals has asked the FDA to require bioequivalency (BE) evidence for all oral products containing oxandralone to show that they interact with anticoagulants containing warfarin in the same way that Savient’s brand version of oxandralone does.
While the debate over FDA user fees for generic drugmakers has remained dormant in recent years, that doesn’t mean the idea might not come back again, said one agency official.