Electronic Common Technical Document (eCTD)

Sdílet
Vložit
  • čas přidán 28. 07. 2021
  • Jonathan Resnick, project management officer for the Division of Data Management Services and Solutions, discusses the Electronic Common Technical Document (eCTD), recent updates, common errors, frequently asked questions, and information about the Technical Rejection Criteria for Study Data (TRC).
    Learn More at: www.fda.gov/dr...
    _______________________________ 
    FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.  

    Upcoming Training - www.fda.gov/cd...
    SBIA Listserv - public.govdeli...
    SBIA 2021 Playlist - • 2021 CDER Small Busine...
    SBIA LinkedIn - / cder-small-business-an...
    SBIA Training Resources - www.fda.gov/cd...
    Twitter - / fda_drug_info
    Email - CDERSBIA@fda.hhs.gov
    Phone - (301) 796-6707 I (866) 405-5367

Komentáře •