FDA Final Guidance for Industry: ANDA Submissions

Amendments to Abbreviated New Drug Applications under GDUFA

On July 3, 2018, the FDA published the final guidance for industry entitled ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.

This final guidance explains how the review goals established as part of the Generic Drug User Fee Amendments (GDUFA II) apply to amendments to Abbreviated New Drug Applications (ANDAs) and prior approval supplements (PASs) submitted to the FDA under section 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(j)). It describes amendment classifications and categories and explains how amendment submissions, including updates or changes to a drug master file (DMF) referenced in an ANDA, may affect an application’s review goal dates.

The final guidance also provides additional clarity on the types of facilities related deficiencies that FDA will classify as major, including:

  • Deficiencies that indicate one or more facilities were found inadequate at the time of action
  • Deficiencies that indicate the submission failed to identify facilities required to be listed in the application
  • A new facility that requires comprehensive evaluation

The ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA final guidance finalizes the October 2017 draft version of the guidance. It also supersedes the December 2001 guidance for industry, Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications and the July 2014 draft guidance for industry: ANDA Submissions – Amendments and Easily Correctable Deficiencies under GDUFA, both of which are being withdrawn.

As part of the Commissioner’s Drug Competition Action Plan, the FDA is publishing this guidance to assist in streamlining the ANDA assessment process, provide clarification and assistance to current and potential applicants, and ultimately expand access for patients to lower cost, high quality medicines.

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