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ABOUT THIS WEBINAR

This webinar will discuss the following new FDA’s labeling resources for human prescription drugs for pharmaceutical industry members:

• The FDA’s Labeling Resources for Human Prescription Drugs webpage includes searchable labeling and product databases and explains how “current” labeling that is submitted by companies to the FDA (e.g., labeling that appears on DailyMed and FDALabel) may differ from the last FDA-approved labeling.
• The Prescribing Information Resources webpage includes a sample template for the Prescribing Information and specific resources for each section of the Full Prescribing Information.
• The Patient Labeling Resources webpage includes answers to questions about Instructions for Use, Medication Guides, and Patient Package Inserts.
• The Carton and Container Labeling Resources webpage includes carton and container labeling regulatory provisions, guidances, and manuals of policies and procedures (MAPPs).
• The Generic Drugs – Specific Labeling Resources webpage includes information about requirements for generic drug labeling, recommendations on updating generic drug labeling, and generic drug labeling guidances and MAPPs.
• The Biological Products – Specific Labeling Resources webpage includes biosimilar and interchangeable biosimilar guidances, the “deemed BLA” guidance, and nonproprietary biological product nomenclature guidances and MAPPs.
• The Selection of Appropriate SPL Codes for Human Prescription Drug Labeling webpage includes recommendations for Structured Product Labeling (SPL) developers in selecting the appropriate SPL codes for human prescription drug labeling.

Additionally, this webinar will discuss a new prescription drug labeling resource for healthcare professionals and patients: Frequently Asked Questions about Labeling for Prescription Medicines.

INTENDED AUDIENCE

The intended audience of this webinar are pharmaceutical industry members who:

• Work on developing labeling for prescription drugs, including “branded” drugs (regulated under NDAs) and biological products (regulated under BLAs), and generic drugs regulated under ANDAs. Prescription drug labeling includes the Prescribing Information, FDA-approved patient labeling (e.g., Medication Guides, Patient Package Inserts, and Instructions for Use), and carton and container labeling.
• Access FDA labeling databases (e.g., Drugs@FDA, FDALabel, Pediatric Labeling Database) and FDA product databases (e.g., Biosimilar Product Information, CDER’s novel drug and biological products, Drug Safety Communications, Drug Trials Snapshots, NDC Directory, Orange Book, Purple Book).
• Develop Structured Product Labeling (SPL) for human prescription drugs.

LEARNING OBJECTIVES

Learning objectives for this webinar are the following:

• Provide an overview of FDA’s labeling resources for human prescription drugs.
• Distinguish between “current” labeling that is submitted by companies to the FDA (e.g., labeling that appears on DailyMed and FDALabel) and the last FDA-approved labeling.
• Discuss available searchable labeling and product databases.
• Locate specific Prescribing Information resources including resources for each section of the Full Prescribing Information and a sample Prescribing Information template.
• Describe resources for Instructions for Use, Medication Guides, and Patient Package Inserts.
• Identify carton and container labeling resources.
• Discuss labeling resources for specific product categories including generic drugs and biological products.
• Discuss a resource for SPL developers in selecting the appropriate SPL codes for human prescription drug labeling.
• Review a new prescription drug labeling resource for healthcare professionals and patients.

FDA SPEAKER

Eric Brodsky, M.D.
Associate Director, Labeling Policy Team
Office of New Drug Policy (ONDP)
Office of New Drugs (OND) | CDER | FDA

FDA RESOURCES

• FDA’s Labeling Resources for Human Prescription Drugs
• Prescribing Information Resources
• Patient Labeling Resources
• Carton and Container Labeling Resources
• Generic Drug – Specific Labeling Resources
• Biological Product - Specific Labeling Resources

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