FDA announces a 10/31 ICH Global Meeting on E8 Guideline on General Considerations for Clinical Trials to discuss a planned revision to the document....
Becton Dickinson recalls its Alaris Infusion Sets due to the potential for faster than expected delivery of medication (over-infusion) or an unintende...
Presenters at an FDA/Duke Margolis Center conference discuss FDA interest in risk-based quality management, including clinical trial monitoring.
FDA is expected to act by mid-2020 on an Allergan NDA for Bimatoprost SR indicated for reducing intraocular pressure in patients with open-angle glauc...
The Office of Generic Drugs science and research report for FY 2018 says 13 research contracts and 11 grants for innovative research were funded.
Federal Register notice: FDA submits to OMB an information collection extension for Center for Devices and Radiological Health Appeals Processes.
Novartis says it has reserved about $700 million to settle U.S. government allegations that it illegally enticed physicians to prescribe its drugs.
FDA accepts for review a Horizon Therapeutics NDA for a new dosage form for Procysbi (cysteamine bitartrate) delayed-release oral granules in packets...