A Consumer Reports investigative report says FDA showed no urgency in 2018 to take action against a dietary supplement with opioid-like effects.
The Biden administration adds former FDA chief of staff Lauren Silvis to its Covid-19 response team.
Aquestive Therapeutics says that feedback from FDA has put it on a clear path to resubmit its NDA for Libervant (diazepam) Buccal Film for managing se...
FDA grants accelerated approval to Sarepta Therapeutics NDA for Amondys 45 (casimersen) injection for treating exon 45 skipping Duchenne muscular dyst...
Three Hogan Lovells attorneys predict an increase in FDA enforcement action against health-related claims in product labeling.
Panelists at a virtual digital health conference say FDA enforcement discretion in their arena is ambiguous.
The Biden Administration shifts in its consideration of both acting commissioner Janet Woodcock and former FDA principal deputy commissioner Joshua Sh...
FDA says it is allowing undiluted frozen vials of the Pfizer-BioNTech Covid-19 Vaccine to be transported and stored at conventional temperatures commo...