Doctors surveyed by the Biologics Prescribers Collaborative say they favor a meaningful four-letter suffix denoting the manufacturers name for biosimi...
FDA says that Bayers controversial Essure permanent birth control system has new labeling that includes a Boxed Warning and a Patient Decision Checkli...
Attorney James Beck looks at five ways that a Trump administration could affect FDA and its regulated industries.
The CDER Office of Pharmaceutical Quality solicits proposals from drug companies wanting to participate in an agency site visit program.
In its latest batch of Warning Letters, FDA cites Morton Drug Co. and Sekisui Medical Co.
FDA approves Medtronics Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator (CRT-D) SureScan device for patients with heart failure.
Federal Register Notice: FDA asks for comments on a new information collection related to an anti-tobacco campaign.
Federal Register Notice: FDA issues a debarment order against Paul S. Singh for providing services in any capacity to a person that has an approved or...