At the end of July, FDA released a tangible plan for promoting innovation in the development of digital health products. In this Digital Health Innovation Action Plan, FDA acknowledges that digital health technologies are critically important in advancing health care, and that traditional FDA pathways to market are not well suited for all of
On October 24, 2016 the Food and Drug Administration (“FDA”) in conjunction with the Centers for Medicare & Medicaid Services (“CMS”) announced their intention to extend the Parallel Review pilot program indefinitely. The Parallel Review process is intended to provide timely feedback on clinical data requirements from FDA and CMS, and minimize the time required
Our colleagues at Epstein Becker Green have issued a client alert: “CMS Issues Final Regulations on Federal ‘Sunshine’ Law for Manufacturers and GPOs,” by Amy K. Dow, Wendy C. Goldstein, Kim Tyrrell-Knott, Sarah K. diFrancesca, David C. Gibbons, Daniel G. Gottlieb, and Natasha F. Thoren.
Following is an excerpt:
On February 1, 2013,