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....
PhRMA raises issues about the CDER Quality Management Maturity and Knowledge-Aided Assessment and Structured Application programs to be considered by ...
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.
