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Apr 11 2013

New FDA Guidances for March 2013

FDA released several interesting new guidances last month, including several regarding communications with the FDA. Types of Communication During the Review of Medical Device Submissions is in accordance with the MDUFA III goals and includes descriptions of acceptance review communications, substantive interactions, interactive review, and missed MDUFA decision communications.

Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors of Applicants is in response to performance goals set out in the Biosimilar User Fee Act of 2012.  Watch for a review of this guidance in the coming weeks!