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FDA Issues 54 Product-Specific Guides In Bid To Spur Generic Competition

September 13, 2018
FDA issued 54 product-specific drug guidances -- 42 new and 12 revised -- on Thursday (Sept. 13), saying the guidances will encourage generic drug development and increase patient access to generic and complex drugs, including those that currently lack competition. The agency last issued a batch of 43 product-specific guidances in July detailing how generic drug developers can copy brand drugs. Inside Health Policy reported at the time that generic drug developers, namely the Association for Accessible Medicines, had...


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