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- FDA Releases Updated Guidance on Clinical Trial Conduct During COVID-19 Pandemic
FDA Releases Updated Guidance on Clinical Trial Conduct During COVID-19 Pandemic
April 2, 2020, Covington Alert
On March 27, the U.S. Food and Drug Administration (FDA) updated its guidance entitled “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic” (Updated Guidance).
July 23, 2020, Covington Alert
FDA announced this week that it intends to extend its enforcement discretion policy regarding investigational new drug (IND) and premarket approval requirements for certain regenerative medicine products through May 2021. In light of the COVID-19 emergency, manufacturers will have six additional months after the initial November 2020 deadline to prepare and ...
March 19, 2020, Covington Alert
The U.S. Food and Drug Administration (FDA) released guidance on March 18, 2020 entitled “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic” (Guidance).1 The Guidance comes at a critical time, as clinical trial sponsors, investigators, and Institutional Review Boards (IRBs) grapple with the measures needed to ensure the ...
November 21, 2017, Covington Alert
In a July 7, 2017 post to the FDA Voice blog, FDA Commissioner Scott Gottlieb announced that FDA would be releasing a “comprehensive regulatory framework” for regenerative medicine products. On November 16, 2017, FDA issued four guidance documents outlining certain aspects of that framework. This alert summarizes each of the guidance documents and highlights ...