Drug Master File (DMF) Submissions on New FDA Form 3938 скачать в хорошем качестве

Drug Master File (DMF) Submissions on New FDA Form 3938

How will eCTD format requirements and Form 3938 change your drug master file (DMF) submissions? The new electronic Form 3938 will provide a standardized fillable electronic form to accompany all new DMF submissions, DMF amendments and annual reports. Form 3938 will not only standardize the required material but will capture all relevant DMF submission information in the eCTD format and allow for the automated pull of DMF information into FDA databases. FDA walks through a mock form completion and address questions. Presenters: CDR David Skanchy– Chemist Vathsala Selvam – Technical Information Specialist Division of Lifecycle API | Office of New Drug Products | Office of Pharmaceutical Quality | CDER _______________________________  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 - [email protected]   Phone - (301) 796-6707 I (866) 405-5367