Huma Therapeutics has been granted Class II clearance from the FDA ... Device (SaMD) disease management platform, dramatically expanding the range of services it can deliver. Class II approval ...

The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.

The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.

Our FDA/Food ... in-process sampling Process monitoring and control decisions that result in minor equipment and process adjustments do not need additional quality unit approval under certain ...

in a profound change at the F.D.A.: a speeding up of the drug approval process. Ms. Pazdur’s three-year battle with cancer was a factor, they say, in Dr. Pazdur’s willingness to swiftly ...

Up to €37.5m of Median’s funding comes from the EIB, and €10m from an equity line with IRIS Capital Investment.

For the first time in two decades, the Food and Drug Administration (FDA) has approved a new class of medication that provides an alternative to addictive opioids for patients looking to manage ...

independence and transparency in Canada’s drug approval process. COVID-19 has exacerbated a backlog of domestic and foreign drug manufacturing inspections that the FDA is still too short-staffed ...