Sen. Charles Grassley asks FDA commissioner Scott Gottlieb to support legislation to increase access to and lower the price of drugs.
FDA approves a Shire NDA for Mydayis (mixed salts of a single-entity amphetamine product), a once-daily treatment comprising three different types of ...
Federal Register notice: FDA seeks comments on an information collection extension for FDA Rapid Response Surveys OMB Control Number 09100500.
Vascular Solutions begins a recall of its Venture catheter because there is a risk of the catheter tip splitting or separating during use.
FDA advisors say trial data indicate that Victoza 1.8 mg injection reduces cardiovascular risk in patients with Type 2 diabetes.
An ongoing FDA/European Medicines Agency pilot program on good clinical practice inspections shows promising results that could lead to greater harmon...
The New York Times reports that critics say that some aspects of a draft administration executive order on drug prices could increase prices rather th...
CDER Office of Testing and Research director Lucinda Buhse tells a Drug Information Association session that the agency has seen growing drug industry...