Arca Biopharma submits a special protocol assessment request for its planned Phase 3 clinical development program of Gencaro (bucindolol hydrochloride...
FDA issues a Pharming Group complete response letter on its supplemental BLA for Ruconest [C1 esterase inhibitor (recombinant)] to expand the current ...
AdvaMed gives FDA recommendations for ways to reduce risk in pediatric medical device development.
FDA clears an Olympus 510(k) for its EZ Shot 3 Plus 25 G needle as well as an expanded indication for the EZ Shot 3 Plus product line for both fine ne...
The Clinical Trials Transformation Initiative reports on its public meeting on best practices and needed resources for advancing use of real-world evi...
FDA publishes a guidance with labeling and safety testing recommendations for heparin-containing medical devices and combination products.
PhRMA calls on FDA to finalize a draft guidance on collecting patient experience data in a timely manner so the guidance may help drug sponsors.
FDA approves a new opioid analgesic REMS that now covers immediate-release products and expands provider education requirements.