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.
FDA warns Milbar Laboratories about CGMP violations in its manufacturing of finished pharmaceuticals.
FDA publishes a draft guidance on in vitro and in vivo studies to establish bioequivalence of the test and reference metered dose inhalers containing ...
An Illinois federal court enters a permanent injunction against three related firms to stop them from selling adulterated and misbranded dietary suppl...
FDA accepts for review an EMD Serono NDA resubmission for cladribine tablets for treating patients with relapsing forms of multiple sclerosis.
FDA approves Medtronics Implantable System for Remodulin for treating patients with pulmonary arterial hypertension.
FDA releases its latest batch of Warning Letters that include Anigan, Milbar Laboratories and Yuki Gosei.