FDA Drug Competition Action Plan | Improving the efficiency of the generic drug development, review, and approval process
By clarifying FDA’s regulatory expectations for new entrants and experienced drug developers alike, FDA is supporting prospective generic drug developers and improving the overall quality of ANDAs submitted to the Agency for approval. At the same time, FDA is implementing initiatives to enhance its own review process efficiency to improve the speed and predictability of the generic drug review process while maintaining our rigorous scientific standards.
To view the guidances listed below, go to Guidances for Drugs and filter by category Drug Competition Action Plan
- Draft Guidance for Industry: Handling and Retention of BA and BE Testing Samples (March 2024)
- Final Guidance for Industry: Controlled Correspondence Related to Generic Drug Development (March 2024)
- Final Guidance for Industry: Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry (January 2024)
- Final Guidance for Industry: ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs (January 2024)
- Guidance for Industry: Requests for Reconsideration at the Division Level Under GDUFA (January 2024)
- MAPP Revision: Filing Review of ANDAs (October 2023)
- Guidance for Industry: Post-Warning Letter Meetings Under GDUFA (September 2023)
- MAPP Revision: ANDA Suitability Petitions (September 2023)
- Guidance for Industry: Cover Letter Attachments for Controlled Correspondences and ANDA Submissions (June 2023)
- MAPP: Assessment of Facility-Based Deficiency Major-to-Minor Reclassification Requests (June 2023)
- Final Guidance for Industry: Assessing User Fees Under the Generic Drug User Fee Amendments of 2022 (June 2023)
- Guidance for Industry: Controlled Correspondence Related to Generic Drug Development (December 2022)
- List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (Updated December 2022, June 2022, December 2021 (added OTC products), June 2021, December 2020, June 2020, December 2019, June 2019, December 2018, June 2018, December 2017; originally published June 2017)
- Guidance for Industry: Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe (December 2022)
- Final Guidance for Industry: ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (December 2022)
- Final Guidance for Industry: ANDA Submissions – Prior Approval Supplements Under GDUFA (October 2022)
- Final Guidance for Industry: Information Requests and Discipline Review Letters under GDUFA, and an accompanying Manual of Policies and Procedures, Issuance of Information Requests and/or Discipline Review Letters for Abbreviated New Drug Applications (MAPP 5220.5) (October 2022)
- Guidance for Industry: Review of Drug Master Files in Advance of Certain ANDA Submissions under GDUFA (October 2022)
- Guidance for Industry: Facility Readiness: Goal Date Decisions Under GDUFA (October 2022)
- Final Guidance for Industry: Competitive Generic Therapies (October 2022)
- Revisions to the Prioritization of the Review of Original ANDAs, Amendments, and Supplements MAPP (October 2022, November 2017, June 2017)
- A public docket to solicit comments on Appendix A of FDA’s July 2018 Guidance Entitled ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA (August 2022)
- Draft Guidance for Industry: Evaluation of Therapeutic Equivalence (July 2022)
- Final Guidance for Industry: Good ANDA Submission Practices (January 2022)
- Draft Guidance for Industry: Revising ANDA Labeling Following Revision of the RLD Labeling (January 2022)
- Draft guidance for Industry: Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe (September 2020)
- Final guidance for Industry: ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs (September 2020)
- Draft Guidance for Industry “Transdermal and Topical Delivery Systems – Product Development and Quality Considerations” (November 2019)
- Draft Guidance for Industry: Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process (July 2019)
- Draft Guidance for Industry: Using the Inactive Ingredient Database (July 2019)
- Updates to FDA’s website on Patent Certifications and Suitability Petitions (June 2019)
- Final Guidance for Industry: Determining Whether to Submit an ANDA or a 505(b)(2) Application (May 2019)
- Draft Guidance for Industry: CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality (February 2019)
- Draft Guidance for Industry: ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs (January 2019)
- Final Guidance for Industry: Amendments to Abbreviated New Drug Applications Under GDUFA (July 2018)
- Draft Guidance for Industry: Good ANDA Submission Practices (January 2018)
- MAPP: Good ANDA Assessment Practices (January 2018)
- Addition of patent submission dates to Approved Drug Products with Therapeutic Equivalence Evaluations – known as the “Orange Book” – where available (November 2017)
- Draft Guidance for Industry: ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) (November 2017)
- Updated Practice – FDA will issue product-specific or product-class specific guidance on how generic copies of newly approved, non-complex new chemical entity drugs can be developed, and make such guidance available at least two years prior to the first lawful ANDA submission date. (October 2017)