The US Food and Drug Administration (FDA) has revised its manual of policies and procedures (MAPP) for conducting a filing review of an abbreviated new drug application (ANDA) by the Office of Generic Drugs’ (OGD) Division of Filing Review (DFR).
This revision is the first since 2017 and went into effect on 3 October 2023.
FDA evaluates each submitted ANDA individually to determine whether the ANDA can be received. Received ANDAs have been verified as complete applications that contain all the required data sets and supporting information, the updated policy notes.
“The receipt of an ANDA means that FDA made a threshold determination that the ANDA is a substantially complete application, that is, an ANDA that on its face is sufficiently complete to permit a substantive review,” the agency wrote.
“Substantially complete” means that the application contains everything required under section 505(j)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and none of the deficiencies described in in 21 CFR 314.101(d) and (e).
After this initial review, the reviewer determines whether to accept the ANDA or whether it needs additional work. If more information is needed, the reviewer will send an Information Request (IR) to the applicant, allowing them to address the problematic areas. The reviewer also has the option to issue a refuse-to-receive notification…
