Still submitting paper to CDER? Send electronically with CDER’s NextGen Portal instead!

CDER’s Jonathan Resnick discusses CDER’s NextGen Portal which is designed to allow a sponsor who normally submits in paper to easily transmit an electronic version instead. Resnick discusses the different submission mechanisms (ESG, CDER NextGen Portal, CDER Direct) to submit to CDER, when to use and when not to use CDER NextGen Portal (i.e., eCTD vs non-eCTD, CDER Submission vs CBER Submission), how to register an account on the CDER NextGen Portal.

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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

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