Today, September 1, 2017, the FDA published a new section of the Manual of Policies and Procedures (MAPP 5200.14), “Filing Review of Abbreviated New Drug Applications.”
This MAPP outlines the policies and procedures for the conduct of a filing review of an abbreviated new drug application (ANDA) by the Division of Filing Review (DFR), Office of Regulatory Operations in the Office of Generic Drugs. This includes DFR Reviewer responsibilities when determining whether an ANDA submission is sufficiently complete and may be received for review.
Of note, this MAPP includes DFR’s current ANDA Filing Checklist. The checklist is a general tool designed to assist the DFR Reviewer in assessing the information and data contained in the submission.
Direct link to the MAPP:
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