The Justice Department says Lehigh Valley Technologies, a human drug developer, is settling a False Claims Act suit charging it with fraudulently obta...
Three stakeholders comment and make suggestions on an FDA draft guidance on biomarker qualification.
Physio-Control begins a Class 1 recall of its LifePak 15 monitor/defibrillator because the device may lockup after a shock is delivered.
Two stakeholders voice support for FDA guidance addressing nontruthful and misleading communications about biologics and biosimilars.
Federal Register notice: FDA submits to OMB an information collection extension entitled Formal Dispute Resolution; Appeals Above the Division Level....
Federal Register notice: FDA makes available a draft guidance entitled Quality Considerations for Continuous Manufacturing.
Timothy Schell leaves industry to return to FDA to lead CVMs the Office of Surveillance and Compliance.
CBER issues a guidance to help biological product manufacturers submit lot release protocols in electronic format.