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PANDEMIC ALTERS POLICIES FOR DRUG DEVELOPMENT
Applied Clinical Trials ; 30(12):8, 2021.
Article in English | ProQuest Central | ID: covidwho-20244569
ABSTRACT
The desperate need for new vaccines and therapies to tame the deadly COVID-19 virus required new policies and procedures for how biopharma companies select, test, and manufacture medical products-and revised regulatory practices for evaluating clinical data, manufacturing operations, and procedures for submitting and analyzing information. Vaccine experts at the Center for Biologics Evaluation and Research (CBER) worked overtime to clarify the size and diversity of efficacy trials and key analytical assessments needed to gain EUA status and later full approval, establishing standards and procedures that will shape research for health emergencies to come. Officials at FDA's Office of Regulatory Affairs (ORA) indicate that the agency will continue to utilize many of these strategies for streamlining oversight of manufacturing operations, even as on-site visits increase overseas and at home, leading to a more "hybrid" inspection process going forward.
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Collection: Databases of international organizations Database: ProQuest Central Type of study: Experimental Studies / Prognostic study Topics: Vaccines Language: English Journal: Applied Clinical Trials Year: 2021 Document Type: Article

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Collection: Databases of international organizations Database: ProQuest Central Type of study: Experimental Studies / Prognostic study Topics: Vaccines Language: English Journal: Applied Clinical Trials Year: 2021 Document Type: Article