FDA approves two Grifols blood screening assays: Procleix Ultrio Elite and Procleix WNV.
FDA solicits stakeholder input on the latest version of its software precertification program working model.
FDA says it continues to evaluate information from several sources, including endovascular graft system manufacturers, about the risks associated with...
A New Jersey federal court blocks Dr. Reddys launch of a generic form of Indiviors Suboxone.
A bipartisan group of senators asks FDA for a report to Congress on the root causes of drug shortages.
FDA solicits stakeholder input on the latest version of its software precertification program working model.
Federal Register notice: FDA posts a list of information collections that have been approved by the Office of Management and Budget.
Federal Register notice: FDA makes available a draft guidance entitled S9 Nonclinical Evaluation for Anticancer Pharmaceuticals Questions and Answers...