USP and Public Policy

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USP Comments to FDA on Draft Guidance for Industry on Third-Party Certification Program for Foods and Feeds (2008)
USP comments to FDA for Docket no. FDA-2008-D-0381 Draft Guidance for Industry on Voluntary Third-Party Programs for Food and Feeds. Comments were submitted in 2008. Learn More
USP Comments to Congress on PREVENT Pandemics Act (2022)
USP Comments to Congress in 2022 regarding the draft of the “Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act” (“PREVENT Pandemics Act”. Learn More
USP comments to FDA on Revocation of Methods of Analysis Regulation (2022)
USP comments to FDA on Docket No. FDA-2020-N-1383 – Revocation of Methods of Analysis Regulation. Comments were submitted in 2022.  Learn More
USP comments to FDA on the Generic Drug User Fee Amendments (GDUFA) program (2020)
USP comments to FDA on Docket No. FDA-2020-N-1459; Generic Drug User Fee Amendments. Comments were submitted in 2020.  Learn More
USP comments to FDA on Guidance For Industry on Microbiological Quality Considerations in Nonsterile Drug Manufacturing (2021)
USP comments to FDA on Docket No. FDA-2021-D-0432 for “Microbiological Quality Considerations in Non-Sterile Drug Manufacturing”. Comments were submitted in 2021.  Learn More
USP Comments to FDA on Draft Guidance of Inspection of Injectable Products for Visible Particulates (2022)
USP comments to FDA on Docket No. FDA–2021–D–0241 for ‘‘Inspection of Injectable Products for Visible Particulates’’ . Comments were submitted in 2022. Learn More
USP comments to FDA on Draft Guidance Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin (2018)
USP comments to FDA on Docket No. FDA-2017-D-5767 for "ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin". Comments were submitted… Learn More
USP comments to FDA on Draft Guidance for Industry, “Q13 Continuous Manufacturing of Drug Substances and Drug Products" (2021)
USP comments to FDA on Docket No. FDA-2021-D-1047 for “Q13 Continuous Manufacturing of Drug Substances and Drug Products”. Comments were submitted in 2021.  Learn More
USP comments to FDA on Harmonizing Compendial Standards With Drug Application Approval Using the USP Convention Pending Monograph Process (PMP) draft guidance (2019)
USP comments to FDA on Docket No. FDA–2019–D–1768; Harmonizing Compendial Standards With Drug Application Approval Using the United States Pharmacopeial Convention Pending Monograph Process. Comments… Learn More
USP comments to FDA on CDER DER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality (2019)
USP comments to FDA on Docket No. FDA-2018-D-4417 for “CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality.” Learn More

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