Five stakeholders generally praise FDA efforts in a draft guidance on key information and facilitating understanding in informed consent.
CBER director Peter Marks and Brown University medical school professor Eli Adashi say it appears that decentralized clinical trials are a paradigm wh...
The National Community Pharmacists Association raises several categories of concerns with FDA in advance of the agencys annual drug compounding listen...
FDA publishes a guidance recognizing the latest revision of the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood ...
Federal Register notice: FDA publishes a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices und...
A National Mucopolysaccharidoses Society commentary urges FDA to use accelerated approval for promising treatments for rare diseases.
Doctors for America calls on FDA to finalize a guidance on collecting race and ethnicity data in clinical trials and clinical studies.
FDA warns Banten, Indonesia-based P.T. Sankei Medical Industries about Quality System and Medical Device Reporting violations in the manufacturing of ...
