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Federal Register notice: FDA withdraws approval of 18 ANDAs from multiple applicants after they notified the agency that the drugs...[ Price : $8.95]
Public Citizen says FDA should disqualify from conducting clinical trials two doctors at the Hennepin County Medical Center and th...[ Price : $8.95]
FDA grants fast track designation to AstraZenecas hyperkalemia drug Lokelma to reduce arrhythmia-related cardiovascular outcomes i...[ Price : $8.95]
FDA qualifies the MED Institutes medical device development tool for virtual MRI safety evaluations of patients with implanted med...[ Price : $8.95]
FDA clears a MIM Software 510(k) for its MIM SurePlan MRT, a software package for molecular radiotherapy.[ Price : $8.95]
FDA grants fast track designation to a Zentalis investigative drug for uterine serous carcinoma.[ Price : $8.95]
The Alzheimers Association and other stakeholders are launching a national registry for Alzheimers diagnostic and treatment inform...[ Price : $8.95]
Two Wiley Rein attorneys suggest ways companies could approach the new FDA section 510(j)(3) drug reporting requirement.