On June 30, 2006, the FDA implemented new regulations for the new content and format of labeling. This webinar will provide a forum for FDA to reflect on its labeling experience over the past year and will include an opportunity for dialogue with FDA representatives concerning the new requirements.
WEBINAR HIGHLIGHTS •Changes in the labeling review process related to the new content and format •Challenges related to the implementation of the new content and format •Updates regarding new FDA guidance documents that support the new regulations.
Organized by:
Drug Information Association
Invited Speakers:
Laurie Beth Burke, MPH, RPh Director, Study Endpoints and Labeling Development Team, OND, CDER FDA United States.
Iris P. Masucci, PharmD Labeling Reviewer, Division of Drug Marketing, Advertising & Comm., CDER FDA United States.