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No More Crying Wolf: FDA Issues Final Rule on Changes to Pregnancy and Lactation Information in Drug Labeling
Session Chair(s)
Tamara Johnson, MD, MS
Acting Team Leader, Division of Pediatrics and Maternal Health, OND, CDER
FDA, United States
This session discusses the final Pregnancy and Lactation Labeling Rule which sets the new content and formatting requirements for pregnancy and breastfeeding information in labeling. Perspectives are provided from the FDA, industry, and academia.
Learning Objective : Describe how to organize pregnancy and lactation recommendations in labeling by the new content and formatting requirements; Explain the rationale for new labeling requirements; Recognize where additional information about drug-associated risks are to be included; Apply knowledge to consolidate pregnancy testing, contraception and infertility information in the dedicated labeling subsection.
Speaker(s)
Overview of the Pregnancy and Lactation Labeling Rule (PLLR)
Jeanine Best, MSN, RN
FDA, United States
Acting Associate Director for Labeling, Office of New Drugs, DPMH, CDER
Implementing the Pregnancy and Lactation Labeling Rule: An Industry Perspective
Christina Bucci-Rechtweg, MD
Novartis , United States
Global Head, Maternal Health and Pediatric Regulatory Policy
Patient and Provider Expectations
Anthony R. Scialli, MD
The Reproductive Toxicology Center , United States
Director
Panelist
Sandra Kweder, MD
Greenleaf Health, United States
Principal, Drug and Biological Products
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