There is no question that GDUFA III has brought with it a lot of changes. OGD has begun issuing Guidances and MaPPs to reflect the changes and updating those document that were issued under previous iteration of GDUFA.  Rather than trying to paraphrase each Guidance and explain what changes have been made in the past 3 days, I have recreated the notice from FDA that I received via email.  Hopefully this will provide you with a road map to many of the changes without having to search all over the CDER webpages.  The following is the text from the email with links to the documents discussed. Enjoy!

The Generic Drug User Fee Amendments (GDUFA) were reauthorized by Congress on September 30, 2022. Known as GDUFA III, these provisions are in effect October 1, 2022, through September 30, 2027.

FDA is committed to ensuring current and prospective abbreviated new drug application (ANDA) applicants have the information they need to successfully submit high-quality ANDAs throughout the GDUFA III cycle. The following resources and publications were published on October 5, 2022. As more publications are posted to FDA.gov, we will send additional announcements.

  • Fiscal Year (FY) 2023 rates for GDUFA III fees (here) For more information, please view the Federal Register Notice.
  • Communicating ANDA Review Status Updates with Industry (here). This MAPP, previously published in September 2017, clarifies the general principles and procedures for communication of ANDA review status updates with the authorized representative for an ANDA applicant, as committed to in GDUFA. This revision includes minor changes intended to reflect GDUFA III commitments.
  • Competitive Generic Therapies Revised Final Guidance (here). This Guidance, previously published in March 2020, describes the process that potential ANDA applicants should follow to request designation of a drug as a competitive generic therapy (CGT), provides information on the actions FDA may take to expedite the development and review of ANDAs for drugs designated as CGTs, and details the criteria for eligibility for 180-day CGT exclusivity. This revision includes minor changes intended to reflect GDUFA III commitments and clarify, among other items, recommendations for pre-ANDA and mid-cycle review meeting requests.
  • Evaluating Requests for and Conducting Product Development and Pre-Submission Pre-ANDA Meetings (MAPP 5220.8, Rev.1) (here). This MAPP, previously published in September 2019, outlines FDA’s policies and procedures for evaluating requests from prospective ANDA applicants for product development and pre-submission pre-ANDA meetings and conducting such meetings. This revision includes minor changes intended to reflect GDUFA III commitments.
  • Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Revised Final Guidance (here) . This Guidance, previously published in November 2020, describes the enhanced pathway for discussions between FDA and a prospective applicant preparing to submit (or an applicant that has submitted) an ANDA for a complex generic drug product to FDA. This revision includes minor changes intended to reflect GDUFA III commitments and clarify the agency’s recommendations for pre-submission, mid-cycle review, enhanced mid-cycle review, and post-complete response letter scientific meeting requests.
  • Information Requests and Discipline Review Letters under GDUFA Revised Final Guidance and Issuance of Information Requests and/or Discipline Review Letters for ANDAs (MAPP 5220.5, Rev. 2) (here). The Guidance, previously published in January 2022, describes how FDA issues and uses information requests (IRs) and discipline review letters (DRLs) during the assessment of an original ANDA. The MAPP describes how FDA issues IRs and DRLs for ANDAs in accordance with GDUFA III. These publications now reflect minor changes intended to reflect GDUFA III commitments.
  • Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA Revised Final Guidance (here). This Guidance, previously published in December 2018, provides recommendations to industry on post-complete response letter (CRL) teleconferences between FDA and ANDA applicants to clarify deficiencies identified in a CRL to an ANDA. This revision includes minor changes intended to reflect GDUFA III commitments and clarify how FDA will conduct post-CRL clarification teleconferences subject to the GDUFA performance goals.
  • Prioritization of the Review of Original ANDAs, Amendments, and Supplements (MAPP 5240.3 Rev. 6) (here). This MAPP, previously updated in January 2020, describes how the review of original ANDAs, ANDA amendments, and ANDA supplements are prioritized for review. This revision includes minor changes intended to clarify certain definitions, revised goal dates in accordance with GDUFA III, and prioritization factors related to applicant requests for priority review and government purchasing or procurement activities documentation.

For additional information, please visit the GDUFA III webpage (here), which features information about GDUFA III enhancements and providing transparency on the progress and performance of FDA’s generic drugs program.