BIO asks FDA to hold more discussions on a draft guidance on collecting racial and ethnicity data in clinical trials and studies.
DuVal & Associates asks the Supreme Court to hear an appeal of a 1st Circuit Court of Appeals decision upholding the conviction of two former Acclaren...
During a Senate Appropriations hearing, FDA commissioner Robert Califf tells lawmakers that the agency is advising against enriched enrollment studies...
FDA accepts for review a Bristol Myers Squibb BLA for a subcutaneous formulation of Opdivo (nivolumab) across all previously approved adult solid tumo...
FDA publishes a final guidance to clarify the distinctions between medical device remanufacturing and servicing.
A BMJ investigation looks at the relationship between several FDA commissioners and the companies the agency regulates.
FDA says Exocel Bio in San Diego is marketing unapproved exosome products.
CDER director Patrizia Cavazzoni provides an update on the reorganization of FDAs Office of Regulatory Affairs (ORA) regarding inspection activities, ...
