PDG on CDER Direct NextGen Collaboration Portal

FDA recently announced a new platform to request pre-ANDA meetings. Because PDG spends a considerable amount of time on complex generic development, we enrolled on day one. Here’s a description, followed by a link to the full story from FDA:

“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.” Here’s the full story as well as a link to contact us for help with your complex drug product.

print