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# FDA Opens NextGen Collaboration Portal
- URL: https://www.fdaweb.com/fda-opens-nextgen-collaboration-portal/
- Published: 2017-10-05T12:00:00.000Z
- Updated: 2026-09-14T22:54:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139799

FDA says industry can now request pre-ANDA meetings for complex generic drug products through CDER’s Direct NextGen Collaboration Portal. An online [post](https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/ucm578012.htm?ref=fdaweb.com) on the portal says the pre-ANDA program is a valuable information resource for generic drug applicants that 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.

Effective 10/1, the post says, industry can submit product development and pre-submission meeting requests for complex generic drug products by uploading meeting requests and meeting packages through the portal in a few simple steps. The portal allows industry to submit supporting documents such as meeting presentation materials, requests for additional information made by FDA, and post-meeting comments.