FDA expands its collaboration with CN Bio, adding research investigating the use of multi-organ microphysiological systems in estimating human drug bi...
FDA deputy commissioner for policy, legislation and international affairs Andi Fristedt says her office continues to have its sights on urging Congres...
FDA posts a draft guidance entitled Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases....
A Texas federal court sides with FDA in a lawsuit opposing the Covid-19 vaccines emergency use authorizations for use in children.
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 ...
