In January 2022, the U.S. Food and Drug Administration (FDA) released finalized guidance on premarket pathways for combination products. While the guidance is not binding, it provides industry ...

Cannabis may be on its way to being less restricted in the U.S. after a recent recommendation from the Health and Human Services Department to reschedule the drug's classification. Last week, the HHS ...

The U.S. Court of Appeals for the D.C. Circuit recently decided in Genus Medical Technologies LLC v. U.S. Food and Drug Administration that, when classifying a biomedical product as either a “drug” or ...