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.
Federal Register notice: FDA announces the rates for biosimilar user fees for fiscal year 2019.
Americans for Homeopathic Choice asks FDA to reconsider its petition that homeopathic drugs will be considered to be new drugs.