Hogan Lovells attorney David Fox says Intarcia has several concerns about the fairness of an advisory committee meeting that the company agreed could ...
House Committee on Oversight and Accountability chairman James Comer begins probe into FDAs recent decision not to regulate cannabidiol products as di...
Federal Register notice: FDA announces an opportunity for public comments on an information collection extension entitled FDA Human Cells, Tissues, an...
Federal Register notice: FDA corrects a 4/11 notice on its Vaccines and Related Biological Products Advisory Committee that contained an incorrect doc...
FDA and RTI International researchers characterize data displays in prescription drug promotions to healthcare providers.
FDA warns East Stroudsburg, PA-based Royal Chemical Company about CGMP violations in its manufacturing of finished drugs.
FDA warns Ottawa, Canada-based Abbott Point of Care about multiple violations in its manufacturing of the i-STAT cTnI test cartridges to measure cardi...
GSK says it will submit an NDA by 6/30 for antibiotic gepotidacin and its use in treating uncomplicated urinary tract infections.
