On August 31, 2020, the Centers for Medicare & Medicaid Services (CMS) proposed a rule to align Medicare coverage decisions with breakthrough technologies approved by the Food and Drug Administration (FDA), thereby speeding...more
On May 14, 2020, the U.S. Food and Drug Administration (FDA) updated its FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency – Guidance for Industry, Investigators, and...more
The Food and Drug Administration (FDA) issued on April 9, 2020 its first emergency use authorization (EUA) for face shields to address the significant shortage of personal protective equipment (PPE) during the COVID-19...more
The Society of Critical Care Medicine estimates that the United States has over 200,000 ventilators, although other organizations have lower estimates. ...more
The Food and Drug Administration (FDA) is increasing and strengthening its ability to enforce criminal sanctions against conduct related to illegal FDA-regulated products across the globe, according to an October...more
Dr. Mark Fleckner, a board-certified New York ophthalmologist, will pay almost $7 million to settle civil fraud claims arising from giving patients imported macular degeneration drugs that had not been evaluated or approved...more
FDA increases enforcement based on clinical research violations. According to recently-posted data, 2014 was a banner year for FDA enforcement based on clinical research violations. ...more