Series Description

FDA's CDER Small Business and Industry Assistance (SBIA) educational webinars target the needs of health care professionals working in the pharmaceutical industry. Subject matter experts from the FDA explain trending drug development topics, (e.g. labeling, adverse events, quality) new guidance's or regulations, and/or FDA regulatory processes. These webinars support FDA's mission of promoting and protecting public health by bridging knowledge gaps about emerging regulatory issues or areas with frequently asked questions.

Lecture Description
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• Discuss the draft guidance for industry, Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling - Content and Format (February 2022).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

References

• Draft guidance for industry, Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling — Content and Format (February 2022).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. Available at https://www.fda.gov/media/155871/download.
• Prescription drug labeling resources at https://www.fda.gov/drugs/laws-acts-and-rules/prescription-drug-labeling-resources
• Immunogenicity Assessment for Therapeutic Protein Products (August 2014) available at https://www.fda.gov/media/85017/download
• Immunogenicity Testing of Therapeutic Proteins Developing and Validating Assays for Anti-drug Antibody Detection (January 2019) available at https://www.fda.gov/media/119788/download
• Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (April 2015) available at https://www.fda.gov/media/82647/download
• Considerations in Demonstrating Interchangeability to a Reference Product (May 2019) available at https://www.fda.gov/media/124907/download

Series Objectives

• Solve FDA drug regulatory issues as they arise.
• Explain new FDA regulatory initiatives.

Learning Objectives After completion of this activity, the participant will be able to:

• Cite why immunogenicity is important to consider for drug development
• Describe the draft guidance for industry, Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling — Content and Format (February 2022).
• Discuss creation of the new dedicated subsection 12.6 for immunogenicity information (Immunogenicity subsection) in the CLINICAL PHARMACOLOGY section of labeling
• State how to develop the Immunogenicity subsection
• Describe when and how to incorporate immunogenicity information in other sections of labeling
• Write recommendations on when to update immunogenicity information in labeling

Target Audience
This activity is intended for physicians, pharmacists, and nurses.

Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.

Disclosure

Faculty

• Brodsky, Eric, MD, Associate Director, FDA/CDER/OND/Labeling Policy Team - nothing to disclose
• Guinn, Daphne, PhD, Regulatory Health Project Manager, FDA - nothing to disclose

Planning Committee

• Kweder, Sandra, MD, Deputy Director, Europe Office - nothing to disclose
• Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose
• Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose

CE Consultation and Accreditation Team

• Harrison, Catherine, CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
• Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose

Registration Information
Registration is complimentary; therefore refunds are not applicable.