In December 2021, FDA issued draft guidance, Digital Health Technologies (DHTs) for Remote Data Acquisition in Clinical Investigations, which provides guidance for clinical trial sponsors, investigators and other interested...more
Manufacturing sites should prepare now for inspections before the U.S. Food and Drug Administration (FDA) resumes routine on-site inspections.
Since 2020, FDA has delayed many routine inspections due to the pandemic. In...more
The U.S. Food and Drug Administration (FDA) issued an update to its guidance document, “Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers,”...more
On March 25, 2020, the Food and Drug Administration (FDA) issued a detail-rich guidance about its “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency” with the...more