An FDA Perspective on FDA Atypical Active Ingredients (On-Demand)

Curriculum

Course DescriptionSteven Wolfgang, Ph.D. Center for Drug Evaluation and Research Office of Compliance Office of Drug Security, Integrity and Response

This presentation from the USP Excipient Stakeholder Forum summarizes the FDA’s current positions on atypical actives, covering issues with GMP, specification and labeling. Examples are presented, including a discussion of responsibilities and challenges ahead.

Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.