Medtronic, as part of the settlement, will pay $602,000 to a whistleblower to settle charges it caused physicians to submit false claims to federal health programs.
Obama gives details on Precision Medicine Initiative
President Barack Obama’s recently unveiled Precision Medicine Initiative hopes to develop a new model of patient-driven research with the promise of accelerating biomedical discoveries and provide clinicians with new tools, knowledge, and therapies.
FDA posted a revised draft guidance document on its brief summary and adequate directions for use concerning risk information in DTC print ads to reflect “recent social science research.”
Public Citizen tells FDA it should withdraw draft guidance that it believes will allow drugmakers to tell physicians marketed drugs are less risky than their labels indicate.