Date:
January 26, 2023
Time:

1:00 p.m. – 2:00 p.m. ET



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ABOUT THIS WEBINAR

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

  • The FDA Labeling Resources for Prescription Drugs for Humans The web page includes searchable labeling and product databases and explains how “current” labeling submitted by companies to the FDA (for example, labeling that appears on DailyMed and FDALabel) may differ from the latest labeling FDA approved.
  • The Prescribing Information Resources The webpage includes a sample template for prescribing information and specific resources for each section of the full prescribing information.
  • The Patient Labeling Resources The webpage includes answers to questions about instructions for use, medication guides and patient package inserts.
  • The Cartons and Containers Labeling Resources The webpage includes carton and container labeling regulations, guidelines, and policies and procedures manuals (MAPPs).
  • The Generic Drugs – Specific Labeling Resources The webpage includes information on generic drug labeling requirements, recommendations on updating generic drug labeling, and guidance on generic drug labeling and MAPPs.
  • The Organic Products – Specific Labeling Resources The webpage includes guidance on biosimilars and interchangeable biosimilars, guidance on “deemed BLA”, as well as guidance on nomenclature of non-proprietary biologics and MAPPs.
  • The Selection of Appropriate SPL Codes for Labeling of Prescription Drugs for Humans The web page includes recommendations for structured product labeling (SPL) developers in selecting appropriate SPL codes for labeling human prescription drugs.

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

TARGETED AUDIENCE

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

  • Work to develop labeling for prescription drugs, including “brand name” drugs (regulated under NDAs) and biologics (regulated under BLAs), and generic drugs regulated under ET UN. Prescription drug labeling includes prescribing information, FDA-approved patient labeling (for example, medication guides, patient package inserts, and instructions for use), and drug labeling. cartons and containers.
  • Access FDA labeling databases (eg, [email protected], FDALabel, pediatric labeling database) and FDA product databases (eg, biosimilar product information, new CDER Drugs and Biologics, Drug Safety Communications, Drug Trials Overviews, NDC Directory, Orange Book, Purple Book).
  • Develop structured product labeling (SPL) for prescription drugs for humans.

LEARNING OBJECTIVES

The learning objectives of this webinar are:

  • Provide an overview of FDA labeling resources for human prescription drugs.
  • Distinguish between “current” labeling submitted by companies to the FDA (for example, labeling that appears on DailyMed and FDALabel) and the latest FDA-approved labeling.
  • Discuss available searchable labeling and product databases.
  • Locate specific prescribing information resources, including resources for each section of the Complete 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 biologics.
  • Discuss a resource for SPL developers in selecting appropriate SPL codes for labeling prescription drugs for humans.
  • Review a new prescription drug labeling resource for healthcare professionals and patients.

LECTURER FROM FDA

Eric Brodsky, MD
Associate Director, Labeling Policy Team
New Medicines Policy Office (ONDP)
New Medicines Office (OND) | CDER | FDA

FDA RESOURCES

CONTINUOUS TRAINING

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

This webinar was:

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

This course was:

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

TECHNICAL INFORMATIONS

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