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A Look Ahead: US FDA And Medical Device Regulations In 2021

The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more

FDA Guidance on Conducting Clinical Trials During the COVID-19 Pandemic

Recognizing the impact of the COVID-19 pandemic on the conduct of clinical trials for drugs and medical devices, on March 18, the Food and Drug Administration (FDA) issued a guidance without prior public comment that is...more

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