Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
The Section 5200.14 of the Manual of Policies and Procedures (MAPP), Filing Review of Abbreviated New Drug Applications is revised. FDA evaluates each ANDA to determine whether an ANDA is substantially complete application and can be received. The MAPP 5200.14 first published in 2017 outlines procedures for reviewing and determining whether an ANDA submission is sufficiently complete by DFR (Division of Filing Review). This revised MAPP also includes an updated ANDA filing checklist.
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