In mid-October, CVM released a draft guidance on a two-phased CMC submission process for ANADA or NADA products. Currently, CMC information is submitted only once. With this draft there can now be two CMC submissions, each with its own review clock, to improve the efficiency of the review. Allows CMC information to be reviewed and cleared prior to the full application. Comments on the guidance are requested before December, 19 2014.
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