Modulated Imaging has received FDA clearance for its Clarifi Imaging System, a diagnostic device that uses spatial frequency domain imaging to help cl...
FDA warns BioDiagnostics International about CGMP and other violations in its manufacturing of finished pharmaceuticals.
FDA grants Daiichi Sankyo a breakthrough therapy designation for quizartinib, an investigational FLT3 inhibitor for treating adult patients with relap...
FDA releases the FDA-483 with six observations from a Sharp Drugs inspection.
The New Civil Liberties Alliance asks FDA to adopt a rule that would require the agency to regulate only through notice-and-comment rulemaking.
FDA commissioner Scott Gottlieb says the agency is working on a new CVM five-year plan to advance antimicrobial stewardship in veterinary settings.
FDA warns Japans Yuki Gosei Kogyo about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
Federal Register notice: FDA announces the fee rates and payment procedures for medical device user fees for fiscal year 2019.