USP and Public Policy

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USP Comment Letter: Submitted to FDA on Quality Metrics Draft Guidance (2016)

USP appreciates the opportunity to comment on the Food and Drug Administration's (FDA) "Request for Quality Metrics Draft Guidance for Industry" (Quality Metrics Draft Guidance). We… Learn More

USP Comment Letter: Submitted to FDA on Biosimilars- Nonproprietary Naming of Biological Products" Draft Guidance for Industry (2015)

USP appreciates the opportunity to comment on the Food and Drug Administration's (FDA) "Nonproprietary Naming of Biological Products" Draft Guidance for Industry" (Draft Guidance). Learn More

USP Comment Letter: Submitted to FDA on Naming Proposed Rule Stamped (2015)

USP appreciates the opportunity to comment on the Food and Drug Administration's (FDA) Proposed Rule, "Designation of Official Names and Proper Names for Certain Biological Products." Learn More

USP Sign-On Letter: Submitted to FDA on Public Standards for Dietary Supplements (2015)

USP supported FDA regarding the value of public standards as they relate to the integrity of dietary supplements. Learn More

USP Comment Letter: Submitted to FDA on Food Safety Modernization Act- Focus on Implementation Strategy (2015)

USP appreciates the Food and Drug Administration’s (FDA) continued work to implement the Food Safety Modernization Act and FDA’s recent Public Meeting to seek comments. Learn More

USP Comment Letter: Submitted to FDA on Compounding Animal Drugs from Bulk Drug Substances (2015)

USP appreciates the opportunity to provide comments to the Food and Drug Administration (FDA) on the “Compounding Animal Drugs from Bulk Drug Substances Draft Guidance for Industry” (Draft Guidance). Learn More

USP Comment Letter: Submitted to FDA on Botanical Drug Development (2015)

USP appreciates the opportunity to provide comments to Food and Drug Administration (FDA) on Botanical Drug Development Draft Guidance for Industry. Learn More

USP Comment Letter: Submitted to FDA on Focused Mitigation Strategies to Protect Food Against Intentional Adulteration (2014)

USP appreciates the opportunity to comment on the U.S. Food and Drug Administration's (FDA) proposed rule on intentional adulterations. Learn More

USP Comment Letter: Submitted to FDA on Biologics Price Competition and Innovation Act (2014)

USP appreciates the opportunity to provide additional input to the Food and Drug Administration (FDA) on draft guidances related to the implementation of the Biologics Price Competition and… Learn More

USP Comment Letter: Submitted to FDA and HHS on OTC System (2014)

USP appreciates the opportunity to comment to the Food and Drug Administration (FDA) as the Agency assess the Over-the-Counter Monograph System (OTC System) and considers possible alternatives. Learn More

USP and Public Policy

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