OTC Monograph Reform: OMOR Format and Content & Electronic Submissions скачать в хорошем качестве

OTC Monograph Reform: OMOR Format and Content & Electronic Submissions

FDA provides an overview of draft guidance for industry entitled Over-the-Counter Monograph Order Requests (OMORs): Format and Content; and a discussion of draft guidance for industry entitled Providing Over-the-Counter Monograph Submissions in Electronic Format. Timestamps 00:37 – Brief Introduction to Monograph Reform 08:46 – Over-the-Counter Monograph Order Requests (OMORs): Format and Content 35:52 – Providing Over-the-Counter Monograph Submissions in Electronic Format 47:38 – Q&A Discussion Panel Speakers | Panelists: Laverdis Davis, MD Medical Officer Division of Nonprescription Drugs II Office of Nonprescription Drugs (ONPD) Office of New Drugs (OND) | CDER | FDA CDR Danielle Terrell (Smith), PharmD, JD, MS Associate Director for Strategic Initiatives ONPD | OND | CDER | FDA 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 2022 Playlist -    • 2022 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