USP and Public Policy

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USP Comment Letter: Submitted to WHO on INN Biological Qualifier (BQ) Proposal (2014)

USP letter provided support to the efforts of WHO’s INN expert group to develop a consensus-based global approach to the naming of all biologicals that is consistent with existing, accepted… Learn More

USP Comment Letter to Federal Trade Commission on Biosimilar Naming (2014)

USP appreciates the opportunity to discuss drug naming at the Federal Trade Commission’s (FTC’s) recent workshop on Follow-On Biologics. USP appreciates FTC’s efforts to help ensure access to quality… Learn More

USP Comment Letter: Submitted to FDA on Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food - FSMA Preventive Controls (2013)

USP appreciates the opportunity to comment on the above-captioned proposed rule related to implementation of the Foods Safety Modernization Act (FSMA) -- preventive controls. Learn More

USP Comment Letter: Submitted to FDA on FSMA International Capacity Building Plan (2012)

USP appreciates the public meeting held by the Food and Drug Administration (FDA) on June 19 to seek input on FDA's international capacity building plan under the FSMA. Learn More

USP Comment Letter: Submitted to FDA on FDA’s International Capacity Building Plan under FSMA (2012)

USP appreciates the public meeting held by the Food and Drug Administration (FDA) on June 19 to seek input on FDA's international capacity building plan under the FSMA. Learn More

USP Comment Letter: Submitted to FDA on NDI Draft Guidance (2011)

The USP submits comments to the Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues (“Guidance”) published by the Food and Drug Administration (… Learn More

USP Comment Letter: Submitted to FDA on “Draft Guidance for Industry on Chemistry, Manufacturing, and Controls, Post-approval Manufacturing Changes Reportable in Annual Reports (2010)

The following are comments of the USP in response to the above-referenced draft Guidance for Industry on post-approval manufacturing changes reportable in annual reports under 21 CFR §314.70. Learn More

USP Comment Letter: Submitted to FDA on Approval Pathway for Biosimilar and Interchangeable Biological Products (2010)

USP appreciates the opportunity to provide input as the Food and Drug Administration (FDA) proceeds with implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). Learn More

USP White Paper: Assuring Quality in Medicines Procurement (2021)

Significant global health gains have been made in the last few decades, in part thanks to increased access to prevention, therapeutics, and services provided by government donors and global financing… Learn More

USP White Paper: Increasing Transparency in the Medicines Supply Chain (2020)

Harnessing information to inform effective action to reduce vulnerabilities and prevent or mitigate disruptions in the global supply of quality medicines. Learn More

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