FDA clarifies policies for reviewing ANDA amendments and supplements
The US Food and Drug Administration (FDA) on Friday 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).The DFR is tasked with reviewing all original ANDAs for completeness and deciding to receive or refuse receipt of the application. In some instances, DFR also reviews amendments to pending ANDAs and prior approval supplements (PASs) to approved ANDAs “to identify deficiencies that, if addressed before assessment by the review disciplines, will streamline the assessment process.”
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 itself 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.
The first attachment features a checklist for staff to follow when reviewing submissions. The newly added second attachment is a work guide providing a more granular overview of when PAS submissions should be routed to DFR.
For instance, the second attachment explains that while all formulation changes that require a PAS should be routed to DFR, “A filing review is not required for changes being effected (CBE) supplements” and that the reduction or removal of an existing flavor or color additive can be included in an annual report and does not require a filing review.
The second attachment also explains that PASs should only be routed to DFR for reintroduced strengths when production is starting up at a new manufacturing site after being discontinued for more than two years. In other cases, PASs for a reintroduced strength will be evaluated on a case-by-case basis “to see if the change may be appropriately submitted as a CBE supplement rather than a PAS.”
FDA