CDER SBIA: Prescription Drug Labeling Conference – Dec. 4-5, 2019

CDER Prescription Drug Labeling Conference Dec. 4-5, 2019 | College Park, MD | Free

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An interactive conference providing information on prescription drug labeling development and discussing recently published FDA labeling guidances.

Agenda Day 1 - Tuesday, December 4 Updating Labeling  Indications and Usage Section of Labeling Draft Guidance and Drug Abuse and Dependence Section of Labeling Draft Guidance Adverse Reaction Information in Labeling  Pediatric Information Incorporated Into Labeling Guidance  The Pregnancy and Lactation Labeling Rule: Four Years In — What’s next?  Labeling Case Study: Transformation of an Indication Labeling Finalization - Improving the Format and Appearance of the Prescribing Information  Improving Structured Product Labeling Submissions  Day 2 - Wednesday, December 5 Labeling for Biological Products A Recipe for Clinical Pharmacology Information in Labeling That is Easy to Digest  Instructions for Use Draft Guidance Product Title and Initial U.S. Approval in Highlights of Prescribing Information Draft Guidance  Drug Product Nomenclature  Safety Considerations for Container Labels and Carton Labeling to Minimize Medication Errors  Improving Consistency of Information in the Prescribing Information and Carton/Container Labeling

INTENDED AUDIENCE

Our 2019 CDER Prescription Drug Labeling Conference is intended for industry, academia, payors, healthcare information providers, and healthcare providers who:

• Review, develop, submit, or use the Prescribing Information, Instructions for Use, and/or carton/container labeling
• Create or submit Structured Product Labeling files to the FDA
• Review, develop, submit, or use the Prescribing Iinformation, Instructions for Use, and/or carton/container labeling
• Create or submit Structured Product Labeling files to the FDA