On January 19, 2017, the United States Food and Drug Administration (“FDA”) unveiled a new drug designation process for regenerative advanced therapies, an important first step toward implementation of the regenerative medicine provisions of the 21st Century Cures Act.  Products for which a designation as a regenerative advanced therapy (“RAT”) is obtained are eligible

Early January has seen the release by FDA of a flurry of information on drug and device manufacturer communications, largely reaffirming FDA’s long-held approach to restricting manufacturer communications regarding off-label uses of approved drugs and medical devices. The most significant positive development arising from these documents is the Agency’s concession on proactive pre-approval communications with

On November 16, the City of Chicago passed an ordinance that will require pharmaceutical sales representatives to become licensed in order to promote prescription drugs to health care providers within city limits.  The ordinance was passed unanimously, despite ardent objections from pharmaceutical manufacturers and industry organizations.  While Mayor Rahm Emanuel states that the new licensing

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,