FDA Released Clinical Trials Guidance for Medical Products Impacted by COVID-19

The FDA issued new guidance to help sponsors assure the safety of trial participants, maintain compliance with good clinical practice (GCP) and minimize the risks to trial integrity during the COVID-19 pandemic.

The FDA plays a critical role in protecting the US from threats including emerging infectious diseases, including the COVID-19 pandemic. FDA is committed to providing timely guidance to support continuity and response efforts to this pandemic.

Given this public health emergency, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.

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