FDA provides an overview of nonprescription drugs, Over-the-Counter (OTC) Monograph Reform, and how FDA identifies and evaluates safety issues. FDA also explains the procedure for FDA-initiated administrative orders to address safety issues and how the public can participate in the administrative order process.
FDA speakers include Valerie Pratt, MD, and Evelyn Mentari, MD, MS from the
Office of Nonprescription Drugs in CDER.
Learn more at: [ Ссылка ]
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 - [ Ссылка ]
SBIA Listserv - [ Ссылка ]
SBIA 2021 Playlist - [ Ссылка ]
SBIA LinkedIn: [ Ссылка ]
SBIA Training Resources - [ Ссылка ]
Twitter - [ Ссылка ]
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
