Quality and Regulatory Predictability: Shaping USP Standards

This session will explore how USP public standards enhance drug quality, simplify product development, facilitate regulatory compliance, and promote greater predictability in regulatory outcomes. Participants will also gain an understanding of how USP standards are created and discover opportunities to contribute, either as sponsors or through public comments, to the development of upcoming standards.

Topics Covered

• FDA’s responsibility in USP standards development
• Value/role of USP monographs for FDA
• Understanding how the use of standards – and demonstrated compliance – factor into FDA’s regulatory activities
• Industry’s position in USP standards development
• Manufacturers’ part in the establishment of USP standards
• Overview of USP standards in regulatory framework
• Discussion of the USP revision process
• How to get involved in monograph development

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