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03.02.21 FDA s COVID-19 PREPP Initiative Summary Report Keys For Manufacturers
This report provides pharmaceutical companies and contract manufacturers a comprehensive analysis of current outsourcing trends and practices, in addition to a quantitative analysis of CMO service quality across a series of 22 performance attributes specific to outsourced drug substance manufacturing. ISR presents data on 358 service encounters from 123 respondents who have been involved in outsourced small molecule API projects in the past 18 months. Preview. Featured Editorial Published in January 2021, the FDA s COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative Summary Report is the culmination of work performed by the FDA’s PREPP Initiative, which launched in April 2020 to examine lessons learned from the agency’s response to the global COVID-19 pandemic. ....