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CDRH Office of Device Evaluation regulatory advisor Joshua Silverstein leaves FDA for an undisclosed private sector job.[ Price : $8.95]
FDA warns Nixa, MO-based Aire-Master of America about CGMP and other violations in its manufacturing of two hand sanitizers.[ Price : $8.95]
CDRH director Jeff Shuren says that life after Covid-19 at the Center could greatly benefit from more regulatory flexibility, whic...[ Price : $8.95]
FDA approves a GSK BLA for Priorix (measles, mumps and rubella vaccine) for use in individuals 12 months of age and older.[ Price : $8.95]
Bristol Myers Squibb withdraws a supplemental BLA for Reblozyl (luspatercept-aamt) for treating anemia in adults with non-transfus...[ Price : $8.95]
The Washington State Supreme Court rules that doctors, and not drug companies, bear responsibility to warn patients about potentia...[ Price : $8.95]
FDA classifies as Class 1 a Philips Respironics recall of all V60 and V60 Plus ventilators because an internal power fluctuation m...[ Price : $8.95]
Federal Register notice: FDA withdraws its guidance entitled Effects of the Covid-19 Public Health Emergency on Formal Meetings an...