Intera Oncology recalls its Intera 3000 Hepatic Artery Infusion Pump due to complaints the device was delivering medications faster than expected.
Federal Register notice: FDA posts two draft guidances entitled Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development....
Federal Register notice: FDA issues bluebird bio a priority review voucher for obtaining approval of Zynteglo (betibeglogene autotemcel), indicated fo...
After reporting Phase 2 data, Bristol Myers Squibb and Janssen Pharmaceuticals say they are planning to begin a Phase 3 trial of their investigational...
FDA posts a safety alert about Philips Respironics recalling certain bi-level positive airway pressure machines that may contain a plastic contaminate...
Federal Register notice: FDA makes available a final guidance for industry entitled E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval...
Federal Register notice: FDA makes available a draft guidance entitled E11A Pediatric Extrapolation.
Federal Register notice: FDA makes available a draft guidance entitled M12 Drug Interaction Studies.
