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

CDER Small Business and Industry Assistance (SBIA) CDER Prescription Drug Labeling Conference Dec. 4-5, 2019 | College Park, MD | Free

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TOPICS COVERED Updating labeling Overview of recently published draft FDA labeling guidances: Indications and Usage section of labeling guidance Drug Abuse and Dependence section of labeling guidance Product Title and Initial U.S. Approval in Highlights of Prescribing Information guidance Adverse reaction information in labeling Specific population information in labeling (e.g., pediatric patients, pregnant patients, lactating patients, and females and males of reproductive potential) Clinical pharmacology information in labeling Product quality information in labeling Labeling for biological products Product nomenclature Improving the format and appearance of Prescribing Information Safety considerations for container labels and carton labeling to minimize medication errors Improving consistency of information in the Prescribing Information and carton/container labeling FDA-approved patient labeling (Instructions for Use) Methods to improve the quality of Structured Product Labeling submissions 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 LEARNING OBJECTIVES Update labeling when submitting New Drug Applications, Biologics License Applications, and/or supplements. Include recommendations from new FDA guidances into future labeling submissions (e.g., indications; pediatric use information; abuse, misuse, addiction, tolerance, and dependence information; and the product title and Initial U.S. Approval in Highlights of Prescribing Information) Discuss considerations for including adverse reaction information in labeling Incorporate pregnancy, lactation, and females and males of reproductive potential information in labeling Revise clinical pharmacology information in labeling according to recently published guidances Develop labeling for biosimilar products Differentiate between different dosage form terminology in labeling Improve the format and appearance of Prescribing Information Decrease risk of medication errors by improving carton/container labeling submissions Ensure consistency of information in the Prescribing Information and carton/container labeling Demonstrate clear, concise, and well-understood Instructions for Use for products that have complicated or detailed patient-use instructions Analyze the quality of Structured Product Labeling file submissions