FDA seeks to eliminate the use of dogs in clinical research by animal drug developers.
CDER Office of Communications associate director Paula Rausch describes how FDA monitors social media and online conversations as a first step in deve...
Two FDA advisory committees vote in a joint meeting to recommend approval of Mallinckrodt subsidiary SpecGxs investigative abuse-deterrent formulation...
PharmaCyte Biotech completes an FDA-required formal report on safety studies using a pig model that were undertaken before getting the agency to sign ...
Three King & Spalding attorneys say the Utah Supreme Court should declare that all medical devices are covered by an unavoidably unsafe tort exception...
The American Medical Association adopts policy to support personal importation of prescription drugs from licensed Canadian brick-and-mortar pharmacie...
Federal Register notice: FDA announces three public meetings entitled Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting Sy...
Federal Register proposed rule: FDA proposes to amend its regulations to implement a provision of the 21st Century Cures Act that would allow an excep...