eCTD Submissions of Promotional Labeling and Advertising Materials

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  • Опубликовано: 19 мар 2023
  • This presentation provided an overview of the updates and revisions between the draft and final versions of the guidance. Topics Covered were the transition period of 24-months for promotional submissions in eCTD format, an overview of changes from the draft to final guidance, and resources available for companies transitioning to eCTD.
    Timestamps
    00:31 - What’s New in the OPDP Electronic Submissions Final Guidance?
    Speakers:
    Jason Cober
    Lead Project Manager
    Office of Prescription Drug Promotion (OPDP) | CDER | FDA
    Learn more at: www.fda.gov/dr...
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