Steven 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.
Subject area:
Excipients
Objectives (If applicable):
n/a
Target Audience (If applicable):