Federal Register notice: FDA announces an 11/7 advisory committee meeting to review an IceCure Medical de novo request for its ProSense Cryoablation S...
FDA says it has added a Warning to labeling for Astellas Veozah about the risk of rare but serious liver injury.
A new National Academies book on collaboration in rare disease drug development lists steps it recommends that FDA take.
FDA publishes a guidance on submitting ANDA amendments under GDUFA 3.
Federal Register notice: FDA determines the regulatory review period for Cyclomedica Australias Technegas (technetium Tc 99m-labeled carbon), indicate...
Federal Register notice: FDA determines the regulatory review period for Marinus Pharmaceuticals Ztalmy (ganaxolone), indicated for treating seizures ...
CDERs Office of Prescription Drug Promotion cites AbbVie in a just-released untitled letter over its television direct-to-consumer advertisement for m...
FDA issues a strategy document on innovative manufacturing technologies with three action steps it will take.
