FDA creates an Office of Digital Transformation, reporting to the commissioner, as part of its ongoing information technology and data modernization e...
FDA posts a revised guidance entitled Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During ...
Three Cooley attorneys say a recent Court of Appeals for the Federal Circuit decision shows how giving inconsistent information to FDA and the U.S. Pa...
Researchers say they see no evidence of continuing problems with generic drug 180-day exclusivity parking that require a congressional solution.
Astellas says an ASPIRO trial patient whose serious adverse event led to the trial being paused and an FDA clinical hold has died.
Two leading House Republicans ask FDA for information on the pressure they say may have come from the White House to approve Covid vaccine booster sho...
FDA acting commissioner Janet Woodcock asks the U.S. Patent and Trademark Office to open a dialog on how the two agencies can work together to promote...
Jacobus Pharmaceutical recalls three lots of Ruzurgi (amifampridine) 10 mg tablets due to potential contamination with yeast, mold, and aerobic bacter...