Daily Rules, Proposed Rules, and Notices of the Federal Government
Submit electronic comments on the draft guidance to
Section 744B(a)(2)(D)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(a)(2)(D)(ii)) (FD&C Act), which was added by GDUFA, Title III, Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), states that, on or after October 1, 2012, a Type II API DMF will be deemed available for reference in an abbreviated new drug application (ANDA), ANDA amendment, or ANDA prior approval supplement (PAS), if the required fee has been paid
Fee amounts and the due date for the fee will be announced in a separate
For DMFs that fail the initial completeness assessment, FDA will issue a letter notifying the holder of the DMF that the DMF is incomplete and identifying missing elements in the DMF that must be addressed. Once the DMF is amended, FDA will re-evaluate it for completeness. This draft guidance describes the criteria that FDA will use in its initial completeness assessment of Type II API DMFs to be referenced in generic drug submissions.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on initial completeness assessments of Type II API DMFs to be referenced in generic drug submissions. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see
Persons with access to the Internet may obtain the document at either