[ Price : $8.95]
CDER issues a MAPP on policies and procedures for notifying NDA and BLA applicants about ARIA safety studies conducted in the Sent...[ Price : $8.95]
FDA announces an 11/13 public workshop on infections related to orthopedic devices and appropriate mitigation measures for protect...[ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes AkivaMed, Oxford Medical Instruments and SilveryGuy.[ Price : $8.95]
The Justice Department charges Teva with paying illegal kickbacks by funding foundations to channel company money to pay Medicare ...[ Price : $8.95]
FDA grants AstraZeneca a priority review for its supplemental BLA for Imfinzi (durvalumab) and a new four-week, fixed-dose regimen...[ Price : $8.95]
FDA places a Poseida prostate cancer drug Phase 1 trial on clinical hold while the company investigates the death of a trial parti...[ Price : $8.95]
FDA clears a 23andMe 510(k) for a pharmacogenetics report for interpretive drug metabolism information on clopidogrel and citalopr...[ Price : $8.95]
FDA posts a catalog of regulatory science tools to help sponsors assess new medical devices.