viernes, 6 de octubre de 2017

New Platform to Request pre-ANDA meetings

New Platform to Request pre-ANDA meetings
On October 1, 2017, the FDA launched a new technology platform, which will allow industry to request pre-ANDA meetings for complex generic drug products with the FDA.  In just a few steps, potential applicants of abbreviated new drug applications (ANDAs) will be able to initiate requests by uploading a meeting request package. The portal also allows industry to submit supporting documents, such as meeting presentation materials, requests for additional information made by the FDA, and post-meeting comments.
This platform, the CDER Direct NextGen Collaboration Portal, was designed to help the FDA minimize manual data entry and support the agency’s GDUFA II performance goals. 
While potential applicants can still email pre-ANDA meeting requests to, the online portal benefits users by ensuring the FDA has all the information needed to review requests and allowing users to view their pre-ANDA meeting request history.

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