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Pre-ANDA Program

Pre-ANDA Program

The Pre-ANDA Program is a valuable information resource for generic drug applicants. The program features product development assistance and pre-submission and mid-review cycle meetings to help clarify regulatory expectations early in product development and during application review.

Industry Can Now Request FDA Pre-ANDA Meetings for Complex Generic Drug Products via CDER Direct NextGen Collaboration Portal

As part of GDUFA II, the FDA committed to developing a program around complex generic drug products to assist ANDA applicants and prospective applicants before they submit an ANDA to the FDA. This assistance program includes pre-ANDA meetings. 

The FDA developed a new technology platform for industry to request pre-ANDA meetings for complex generic drug products, by the CDER Direct NextGen Collaboration Portal (the portal).

Effective Oct. 1, 2017, industry can submit product development and pre-submission meeting requests for complex generic drug products by uploading meeting requests and meeting packages in just a few simple steps.

The portal allows industry to submit supporting documents, such as meeting presentation materials, requests for additional information made by the FDA, and post-meeting comments. 

The FDA is excited to introduce this new online tool which allows for more efficient processing of these meeting requests and is a “one-stop-shop” access to a prospective applicant’s meeting request history.

For questions about submitting Pre-ANDA meeting requests for complex generic drug products online please contact PreANDAHelp@fda.hhs.gov.
 

Pre-ANDA Meeting Useful Links