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Prescription Drug Labeling: New Guidances from the US FDA
Session Chair(s)
Barbara Chong, PharmD
Special Assistant for Labeling, Office of Medical Policy, CDER
FDA, United States
This session will provide updates from the US FDA on the latest developments regarding prescription drug labeling (i.e., Prescribing Information). Topics will include overviews of recently published FDA guidances, including Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products -- Content and Format, Pediatric Information Incorporated into Labeling, Product Title and Initial US Approval in the Highlights of Prescribing Information, and Labeling for Biosimilar Products.
Learning Objective : Discuss labeling updates from the US FDA: Describe recommendations for prescription drug labeling outlined in recently published FDA guidances; Identify labeling information that is relevant for your organization.
Speaker(s)
Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products: Content and Format
Iris Masucci, PharmD
FDA, United States
Special Assistant for Labeling, Office of Medical Policy, CDER
Labeling for Biosimilar Products
Stacey Ricci
US FDA, United States
Director, Scientific Review Staff, OTBB, CDER
Pediatric Information Incorporated into Labeling; Product Title and Initial US Approval in the Highlights of Prescribing Information
Eric Brodsky, MD
FDA, United States
Associate Director, Labeling Development Team, Office of New Drugs, CDER
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