FDA Study Data Technical Rejection Criteria (TRC): What you need to know! скачать в хорошем качестве

FDA Study Data Technical Rejection Criteria (TRC): What you need to know!

FDA is planning to implement eCTD validations in 2021 specific to submissions containing study data. FDA published the TRC to assist industry in understanding when a submission containing study will be subject to these study data eCTD validations. This recording provides an overview of the TRC, a walk-through of resources currently available to help the sponsor/applicant determine if their submission is subject to these eCTD validations, creation of a simplified TS.XPT, and frequently asked questions. Learn more at https://www.fda.gov/drugs/news-events... _______________________________  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 - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2021 Playlist -    • 2021 CDER Small Business and Industry Assi...   SBIA LinkedIn:   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - CDERSBIA@fda.hhs.gov   Phone - (301) 796-6707 I (866) 405-5367