Federal Register notice: FDA announces the continuation of its paired meeting program that aims to advance the use of complex innovative trial designs...
FDA posts a final guidance entitled Human Gene Therapy for Neurodegenerative Diseases.
FDA accepts for review a Bristol Myers Squibb supplemental NDA for Camzyos (mavacamten) for an expanded indication to reduce the need for septal reduc...
FDA posts three FDA draft guidances that provide general recommendations for physicochemical and structural characterization tests, in vitro release t...
A white paper commissioned by Georgetown University says changes are needed at FDA because its evidence standards have become distorted, which have le...
FDA approves expanded labeling on Medtronics SelectSecure MRI SureScan Model 3830 cardiac lead for conduction system pacing.
Federal Register notice: FDA announces the Advancing Real-World Evidence (RWE) Program, which was agreed to under the recent user fee reauthorization....
Federal Register notice: FDA extends the comment period associated with a 9/30 notice on the proposed recommendations for the reauthorization of the A...
