Three stakeholders comment and make suggestions on an FDA draft guidance on biomarker qualification.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Federal Register notice: FDA makes available a draft guidance entitled Quality Considerations for Continuous Manufacturing.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.
The Office of Generic Drugs annual report shows that 1,021 ANDAs were approved or tentatively approved in 2018.