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Collection: Global Health Events web archive
Description: This 24-page guidance was issued to assist sponsors in the clinical development and licensure of vaccines for the prevention of COVID-19, and describes the FDA's current recommendations regarding the data needed to facilitate clinical development and licensure of vaccines to prevent COVID-19.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Center for Biologics Evaluation and Research (U.S.)
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Vaccines
Collection: Global Health Events web archive
Description: The Food and Drug Administration (FDA) has issued this 18-page guidance to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Center for Biologics Evaluation and Research (U.S.)
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Vaccines, Basic Information
Collection: Global Health Events web archive
Description: The Food and Drug Administration (FDA) has issued this 35-page guidance, updated on September 21, 2020, to provide general considerations to assist sponsors in assuring the safety of trial participants in the conduct of clinical trials of medical products, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 (coronavirus) pandemic.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Center for Biologics Evaluation and Research (U.S.) , Center for Devices and Radiological Health, Center for Drug Evaluation and Research
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This 17-page guidance, updated on September 2, 2020, provides recommendations to healthcare providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency. The guidance also provides recommendations to blood establishments on the collection of COVID-19 convalescent plasma.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration, Center for Biologics Evaluation and Research (U.S.)
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information
Collection: Global Health Events web archive
Description: This 12-page guidance provides answers to frequently asked questions about regulatory and policy issues related to inspections, pending drug applications, and changes in manufacturing facilities for approved pharmaceutical products during the COVID-19 epidemic.
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Creator: United States. Food and Drug Administration. Office of Regulatory Affairs, Center for Biologics Evaluation and Research (U.S.)
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information
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