FDA’s Office of Clinical Pharmacology discuss:
-key regulations that impact clinical pharmacology content in prescription drug labeling (also referred to as prescribing information or package insert (PI)),
-where clinical pharmacology content is found in prescription drug labeling,
-content structure of the Clinical Pharmacology section in prescription drug labeling, and
-alternative methods of communicating complex clinical pharmacology content.
CDER presenters include Mongthuong Tran, Kimberly L. Bergman, Eric Brodsky, Joseph A. Grillo, and Catherine Miller.
Learn more at www.fda.gov/Dr...
_______________
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 and free continuing education credits: www.fda.gov/cd...
CDER SBIA 2020 Playlist: • 2020 CDER Small Busine...
LinkedIn: / cder-small-business-an...
Training resources: www.fda.gov/cd...
Twitter: / fda_drug_info
CDER small business e-mail update subscription: updates.fda.go...
Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367
Негізгі бет Presenting Clinical Pharmacology Information in Prescription Drug Labeling - Jun. 19, 2017
Пікірлер