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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

CONTINUING EDUCATION

This webinar has been approved for 1.00 contact hour of continuing education for physicians, pharmacists, and nurses. Please see detailed announcement for more information. After the course concludes, that day's attendees will receive an email with instructions and a code to claim their credit. Only participants who attend the live broadcast via Adobe Connect will receive the claim codes.

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This webinar has been:

• pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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• Please contact [email protected] for all technical questions.
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