pharmaceutical-continuous-manufacturing-regulatory-landscape-spotlight-usp-workshop 
Quality Matters
SEPTEMBER 15, 2023
FDA representatives emphasized the agency’s commitment to working with industry to mitigate potential regulatory hurdles to PCM adoption during USP’s workshop on “ Identifying and Addressing Barriers to Continuous Manufacturing Adoption ” July 18-19 in Rockville, Maryland.
Quality Matters
NOVEMBER 11, 2022
market is putting nitrosamine drug substance related impurities (NDSRI) in the spotlight once again. FDA) workshop , my fellow panelist and I addressed the latest developments in the identification and control of nitrosamines in pharmaceutical products. Earlier this year, at a U.S. Food and Drug Administration (U.S.
Quality Matters
OCTOBER 24, 2023
Mitigating Cancer Drug Shortages: USP-American Cancer Society Summit Issues Call to Action Patient access to cancer drugs can mean the difference between life and death. Pharmacopeial Convention (USP), the American Cancer Society (ACS), and the ACS Cancer Action Network (ACS CAN). 26 by the U.S. 26 by the U.S.
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