Month: July 2018

FDA Releases Draft Guidance Regarding Indications and Usage Section of Drug Labeling

The U.S. Food and Drug Administration (FDA) announced today the availability of a new draft guidance titled, “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.” This draft guidance provides insight into the FDA’s current thinking related to the INDICATIONS AND USAGE section […]

CMS Requests Information Regarding The Stark Law’s Potential Barriers to Coordinated Care

On June 25, 2018, the Centers for Medicare and Medicaid Services (“CMS”) published a Request for Information (“RFI”) in the Federal Register regarding section 1877 of the Social Security Act, also known as the “physician self-referral law” or the “Stark Law”. The Stark Law is a strict liability statute that: […]