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The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
FDA published notices in the Federal Register announcing the availability of two draft guidances for industry:
- Abbreviated New Drug Application (ANDA) Submissions – Amendments and Easily Correctable Deficiencies Under GDUFA, and
- Abbreviated New Drug Application (ANDA) Submissions – Prior Approval Supplements Under GDUFA
These draft guidances are intended to assist applicants preparing to submit amendments to ANDAs, prior approval supplements, and amendments to prior approval supplements under the Federal Food, Drug, and Cosmetic Act, by explaining how the GDUFA performance metrics apply to these submissions.
Pre-recorded webinars explaining these guidances are available at:
- Abbreviated New Drug Application (ANDA) Submissions – Prior Approval Supplements Under GDUFA
- Adobe Connect Link: https://collaboration.fda.gov/p98ulfi2wfd/
- Download Presentation Slides: Prior Approval Supplements Under GDUFA (PDF - 353KB)
- Abbreviated New Drug Application (ANDA) Submissions – Amendments and Easily Correctable Deficiencies Under GDUFA
- Adobe Connect Link: https://collaboration.fda.gov/p2ehqu6hu81/
- Download Presentation Slides: Amendments and Easily Correctable Deficiencies Under GDUFA (PDF - 529KB)
Submit electronic comments on the draft guidances to www.regulations.gov
This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO FDA (1-888-463-6332) or (301) 796-3400 from 8:00 am - 4:30 pm Monday - Friday. You can also email us at druginfo@fda.hhs.gov.
- For additional drug information, please visit the DDI Web page.
- For up-to-date drug information, follow the FDA’s Division of Drug Information on Twitter: FDA_Drug_Info
- This service is provided to you at no charge by the U.S. Food & Drug Administration (FDA).
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