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USP comments to FDA on Draft Guidance Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin (2018)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USP comments to FDA on Draft Guidance for Industry, “Q13 Continuous Manufacturing of Drug Substances and Drug Products" (2021)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Compendial Standards With Drug Application Approval Using the USP Convention Pending Monograph Process (PMP) draft guidance (2019)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
USP comments to FDA on Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Packaging (2019)
USP comments submitted to FDA for Docket No. FDA-2019-N-1845: Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain. Comments… Learn More
USP Comments Submitted to FDA on Continuous Manufacturing (2017)
USP Comments submitted to FDA on Continuous Manufacturing for Docket No. FDA-2017-N-2697 for “Submission of Proposed Recommendations for Industry on Developing Continuous Manufacturing of Solid… Learn More
USP Comments to FDA Public Meeting: “The Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access” Regarding Generic Medicines (2017)
USP Comments to FDA Public Meeting: “The Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access” Regarding Generic Medicines. Comments were submitted 7-18-2017. Learn More

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