US FDA issues CMC draft rules for new NDAs & ANDAs, seeks comments from industry before Sept 23
Wednesday, July 28th, 2010US FDA issues CMC draft rules for new NDAs & ANDAs, seeks comments from industry before Sept 23
US Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER) has issued a draft guidance on chemistry, manufacturing and controls (CMC) which calls for post approval manufacturing changes to drug applicants on the types of changes that are to be included in annual submissions.
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