CDER SBIA Webinar: Writing the “Indications and Usage” Section of Labeling: FDA’s New Draft Guidance - Sept. 27 @ 1:30 PM EDT

CDER SBIA Webinar: Writing the “Indications and Usage” Section of Labeling: FDA’s New Draft Guidance

Thursday, September 27, 2018

1:30 p.m. to 2:30 p.m. EDT

Register Now

WHY ATTEND?

This webinar will provide insight on FDA’s recommendations for the “Indications and Usage” section of labeling as outlined in the draft guidance Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products – Content and Format.  

Webinar participants will hear directly from the FDA on current recommendations for:

• How to write, organize, and format the information in the “Indications and Usage” section
• General principles to consider when drafting the “Indications and Usage” section
• When to include limitations of use in the “Indications and Usage” section

WHO SHOULD ATTEND?

Industry professionals, including (but not limited to) those working in:

• Labeling development
• Medical affairs
• General regulatory
• Promotion and advertising
• Other stakeholders with interests related to prescription drug labeling (e.g., payors)

FDA SPEAKER

Iris P. Masucci, Pharm.D.

Special Assistant for Labeling

Office of Medical Policy

Center for Drug Evaluation and Research

 

CONTINUING EDUCATION

This event is eligible for up to one credit towards a RAC recertification. Only in-person attendance will qualify for the CE. Attendance certificates are only available for two weeks after the event.