Tagged: Food and Drug Administration

Clinical Trials During the COVID-19 Pandemic

Jamie McCarty

In light of the COVID-19 pandemic, the Food and Drug Administration (“FDA”) issued recent non-binding guidance (“Guidance”) on the conduct of ongoing clinical trials of medical products. The FDA acknowledges that the public health emergency may result in unavoidable protocol modifications and/or deviations. Quarantines, site closures, travel limitations, interruptions in the supply chain for the...

FDA Issues Guidance on Drug and Device Manufacturer Communications: Part II – Medical Product Communications that are Consistent with the FDA-Required Labeling

Alex Stoflet

On June 12, the FDA issued guidance that clarifies its recommendations for certain product communications made by medical product manufacturers, packers, and distributors (collectively “firms”). The guidance, “Medical Product Communications That Are Consistent With the FDA-Required Labeling” (the “Guidance”), explains the FDA’s views on firms’ communication of information that is not contained in the FDA-required...