Wednesday, March 30, 2022

SBIA: CME/CNE/CPE Approved Webinar | Immunogenicity Information in Labeling

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CDER SBIA Webinar Registration

FDA | CDER | Small Business and Industry Assistance

WEBINARS

Immunogenicity Information in Labeling

Date: April 5, 2022
Time: 11:00 AM - 12:30 PM ET

Registration

ABOUT THIS WEBINAR

During this webinar, FDA will:

  • Highlight why immunogenicity is important to consider for drug development
  • Discuss the draft guidance for industry, Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling — Content and Format (February 2022). When final, this guidance will represent FDA's current thinking on this topic.
  • Discuss creation of the new dedicated subsection 12.6 for immunogenicity information (Immunogenicity subsection) in the CLINICAL PHARMACOLOGY section of labeling
  • Provide an overview on how to develop the Immunogenicity subsection
  • Describe when and how to incorporate immunogenicity information in other sections of labeling
  • Provide recommendations on when to update immunogenicity information in labeling

FDA RESOURCES

Immunogenicity development guidances:

FDA SPEAKERS

Daphne Guinn, Ph.D.
Regulatory Health Project
Manager

Office of Clinical Pharmacology (OCP)
Office of Translational Science (OTS) | CDER | FDA

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

INTENDED AUDIENCE

  • Pharmaceutical industry staff who include immunogenicity information in labeling for their biological products [specifically human therapeutic protein products licensed under section 351(a) of the Public Health Service Act] and certain select drug products (regulated under section 505 of the Federal Food, Drug, and Cosmetic Act) with immunogenicity assessments (e.g., heparins, oligonucleotides, and peptides).

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