Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA

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Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA

Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA: The purpose of this guidance is to provide recommendations for abbreviated new drug applications (ANDAs) or Prior Approval Supplements (PAS) to holders of Type II active pharmaceutical ingredient (API) DMFs. The “GDUFA Reauthorization Performance Goals and Program Enhancements for Fiscal Years 2023-2027” knowledge is utilized to create this guidance. (GDUFA III commitment letter). Specifically, this guidance describes instances when an early assessment, or “DMF prior assessment”, could be requested by a DMF holder and the circumstances under which FDA would commence an assessment of Type II API DMFs 6 months prior to an ANDA or PAS submission referencing the DMF.  

Essential requisites for DMF prior assessment:

  1. The submission must incorporate at least one Letter of Authorization (LOA) with a pre-assigned ANDA number.
  2. Initial (or) original ANDA submissions a reference to the corresponding reference listed drug (RLD) listed in in FDA’s Orange book must be included.
Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book).
  1. Documentation that the DMF holder has paid a GDUFA DMF fee as described in section744B(a)(2)(A) of the FD&C Act (21 U.S.C. 379j-41(a)(2)(A)).
Conditions for premature assessment: Request for assessment of a DMF 6 months prior to submission of an ANDA or its amendments:

The GDUFA III commitment letter, a holder of a DMF may submit a request for assessment of the DMF 6 months prior to the planned submission date for:

  1. Original ANDA.
  2. ANDA amendment containing a response to a Complete Response Letter (CRL).
  3. Amendment seeking approval of an ANDA that previously received a tentative approval.
DMF for which FDA has not conducted a substantive assessment, and one of the following conditions should be met:
  1. The entire patents and exclusivities will pass away within 12 months of the planned submission date.
  2. Drug Products with no more than three approved drug products in the Orange Book for which there are no blocking patents or unexpired exclusivities listed for the RLD, and the ANDA applicant is not seeking approval for less than all of the conditions of use on the RLD labeling
  3. Drug products that might help moderate or resolve drug famines.
  4. Drug products focusing asserted or predictable public health crises.
  5. Drug products with Orange Book status provisions, including only one permitted ANDA product in the Operating Section.
Request for assessment of a DMF 6 months prior to submission of a PAS to add a new API source:
  1. PAS is for drug products that could help mitigate or resolve drug shortages and prevent future shortages.
  2. PAS is for a drug product that either could help address a public health Emergency declared by the Secretary of the U.S. Department of Health and Human Services
Reference: https://www.fda.gov/media/162019/download
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