FDA revised policies for reviewing ANDA amendments and supplements
The US Food and Drug Administration (FDA) revised its manual of policies and procedures (MAPP) to clarify when certain abbreviated new drug application (ANDA) amendments and supplements should be reviewed by the Office of Generic Drugs’ (OGD) Division of Filing Review (DFR).
OGD’s DFR reviews each original ANDA submitted to OGD to evaluate whether an ANDA may be received or refused for receipt pursuant to FDA’s regulations at 21 CFR 314.101, which provide the regulatory authority by which FDA may in certain cases, and will in others, refuse to receive (RTR) an ANDA. Below are some highlights for change in version 1.4 to 1.5 in M1 eCTD specification.
Changes that would trigger a DFR review of an ANDA amendment or PAS include adding additional strengths to an application; formulation changes; prescription to over-the-counter switches; changes to container closer systems for parenterally administered drugs; and reintroducing strengths that have been off the market for multiple years.
The MAPP also explains the internal processes and procedures for FDA’s documentation room staff in reviewing the cover letters and applications to determine where to route the submission in accordance with two attachments to the MAPP.
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