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  1. Development & Approval Process (Drugs)

Writing the “Indications and Usage” Section of Labeling: FDA’s New Draft Guidance

Writing the “Indications and Usage” Section of Labeling: FDA’s New Draft Guidance

SBIA Webinar 2016

Thursday, September 27, 2018
1:30 p.m. to 2:30 p.m. EDT

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will provide insight on FDA’s recommendations for the “Indications and Usage” section of labeling as outlined in the draft guidance Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products – Content and Format.  

FDA-approved labeling is the primary communication tool for providing information on the safe and effective use of drugs to the medical community. This draft guidance, when finalized, will assist drug and biological product applicants in developing the “Indications and Usage” section of labeling. This will ultimately help health care providers identify appropriate treatment options for their patients.


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


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)


Iris P. Masucci, Pharm.D.
Special Assistant for Labeling
Office of Medical Policy
Center for Drug Evaluation and Research



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.