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...
Federal Register notice: FDA makes available a final guidance #253 entitled Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- a...
FDA publishes a guidance on accounting for multiple endpoints in the analysis of drug and biologic clinical trials.
Talaris says it has informed FDA about the death of a subject in the FREEDOM-1 trial of FCR001 in live donor kidney transplant recipients.
FDA releases the form FDA-483 with two observations from an inspection at Branchburg, NJ-based ImClone Systems.
