FDA Issues New and Revised Guidance for Generic Drugs
By Michael Mezher -
Published 16 May 2017
The US Food and Drug Administration (FDA) on Tuesday released a batch of 21 new and 16 revised draft guidances intended to help drugmakers conduct the studies needed to support the approval of certain generic drugs.
Categories: News, US, FDA, Clinical, Generic drugs, Submission and registration
Tags: Product-Specific Guidance, Bioequivalence