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  4. Still submitting paper to CDER? Send electronically with CDER’s NextGen Portal instead! (for submissions not required in eCTD) - 05/26/2020
  1. News & Events for Human Drugs

Webcast | Virtual

Event Title
Still submitting paper to CDER? Send electronically with CDER’s NextGen Portal instead! (for submissions not required in eCTD)
May 26, 2020

Date:
May 26, 2020

 

View Slides

 

This webinar provides an overview of CDER’s NextGen Portal for those in industry who are currently not required to submit in eCTD and are sending information to CDER in paper. CDER’s NextGen Portal is designed to allow a sponsor who normally submits in paper to easily transmit an electronic version instead.

LEARNING OBJECTIVES

After this webinar, participants will be able to…

  • Understand the different submission mechanism (ESG, CDER NextGen Portal, CDER Direct) to submit to CDER
  • Know when to use and when not to use CDER NextGen Portal (i.e., eCTD vs non-eCTD, CDER Submission vs CBER Submission)
  • Register an account on the CDER NextGen Portal
  • Submit electronically instead of paper through CDER’s NextGen Portal

INTENDED AUDIENCE

  • Research IND Sponsors planning to submit in paper to CDER
  • Type III Drug Master File Holders planning to submit in paper to CDER
  • Sponsors and Applicant Holders who received an eCTD waiver for their NDA, BLA, ANDA, DMF, or Commercial IND and planning to submit in paper to CDER
  • Regulatory affairs professionals submitting marketing and advertising materials in paper to CDER
  • Medical Gas applicants planning to submit in paper to CDER

FDA SPEAKERS

Jonathan Resnick
Project Management Officer
Division of Data Management Services & Solutions | Office of Business Informatics | CDER | FDA

FDA RESOURCES

  1. CDER NextGen Portal
  2. Submitting Research INDs and subsequent amendments via CDER NextGen Portal
  3. For support and questions email: edmsupport@fda.hhs.gov
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