Federal Register notice: FDA classifies prognostic tests for assessing liver-related disease progression into Class 2 (special controls).
The HHS Inspector General says FDA has concurred with recommendations on steps to improve its management of IT acquisition contracts.
Two CDER officials describe work being done under the Biosimilar User Fee Amendments 3.
A Florida woman is sentenced to three years in jail for submitting a false affidavit to an FDA investigator looking into issues with a clinical trial ...
The DC Circuit Court of Appeals says Sanofi was entitled to new chemical entity exclusivity for its Aubagio and Sandoz is not entitled to exclusivity ...
FDA announces a 3/8 workshop entitled Understanding the Use of Negative Controls to Assess the Validity of Non-Interventional Studies of Treatment Usi...
FDA approves Abbotts latest-generation transcatheter aortic valve implantation system, Navitor, for treating people with severe aortic stenosis.
FDA warns Chandler, AZ-based Optum Infusion Services about adulterated sterile drug products.
