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...
FDA warns Nashville, TN-based Pinnacle BioLabs that it is marketing and distributing a diagnostic test for an unapproved indication that also has Qual...
FDA warns Gelderland, Netherlands-based Future Diagnostics Solutions about Quality System and Medical Device Reporting violations in its manufacturing...
The Federal Trade Commission says it is expanding its challenges to junk drug patents with warnings to 10 companies about over 300 patent listings for...
FDA issues a safety alert on the rare risk of intrahepatic cholestasis of pregnancy associated with the use of thiopurines (azathioprine, 6-mercaptopu...
The CDER Office of New Drugs says it participated in 55 novel drug approvals in 2023.
FDA gives Pfizer traditional approval for its previously accelerated-approved Tivdak (tisotumab vedotin-tftv) for recurrent or metastatic cervical can...
