FDA provided an overview of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862).
Timestamps
00:40 - Overview of Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use
29:50 - Q&A Session
Speaker:
Elisabeth Walther, PharmD, JD
Associate Director for Strategic Initiatives
Office of Nonprescription Drugs (ONPD) | CDER | FDA
Panelist:
Same as above.
Learn more at: www.fda.gov/drugs/news-events-human-drugs/overview-fdas-proposed-rule-nonprescription-drug-product-additional-condition-nonprescription-use
-----------------------
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/cdersbia
SBIA Listserv - public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2022 Playlist - ru-vid.com/group/PLey4Qe-UxcxbzCGn90m38cXN2DL2i3VmD
SBIA LinkedIn - www.linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources - www.fda.gov/cdersbialearn
Twitter - FDA_Drug_Info
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
6 фев 2023