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IPQ Inside the global regulatory dialogue

Guides on FDA’s Generic Drug Review Process Continue Apace in July; EU Pilot Pursues Generic Drug Review Streamlining Internationally

Aug 16th, 2014

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The efforts by the Office of Generic Drugs (OGD) to clarify and streamline the Abbreviated New Drug Application (ANDA) process and facilitate the implementation of the Generic Drug User Fee Act (GDUFA) continued apace in...

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