What’s New for Biologics

What’s New for Biologics

• Influenza Virus Vaccine for the 2018-2019 Season
  Posted: 8/30/2018
• August 29, 2018 Approval Letter - JIVI (PDF - 58KB)
  Posted: 8/30/2018
• eSubmitter Download and Installation
  Updated: 8/30/2018; Link to Download Most Common Issues (August 2018) added
•  Webinar - Writing the “Indications and Usage” Section of Labeling: FDA’s New Draft Guidance – September 27
  This webinar will provide insight on FDA’s recommendations for the “Indications and Usage” section of labeling as outlined in the draft guidance titled “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products – Content and Format.”