Healthcare experts offer a plan for comprehensive reform of the U.S. pharmaceutical system.
FDA clears an Additive Orthopedics 510(k) for its Patient Specific 3D Printed Bone Segments for internal bone fixation in the ankle and foot.
The Pennsylvania Superior Court upholds dismissal of a suit alleging a patient died as a result of off-label promotion of Teva/Cephalons Actiq for tre...
Federal Register notice: FDA posts a list of recent information collections that have been approved by OMB.
Federal Register notice: FDA seeks public comments on an information collection extension entitled Electronic User Fee Payment Request Forms Form FDA...
FDA publishes a report with charts of bioresearch monitoring inspections from FY 2017.
FDA issues Evolus a complete response letter on its BLA for potential Botox competitor DWP-450 (prabotulinumtoxinA) for treating glabellar lines.
FDA accepts for review an Insmed NDA for ALIS (amikacin liposome) inhalation suspension for adult patients with nontuberculous mycobacterial lung dise...