July 20, 2021
There are several important differences between FDA regulations of pharmaceuticals and medical devices. These differences span from regulation of promotion and advertising to the testing requirements...
July 16, 2021
The U.S. Federal Trade Commission has undertaken several decisive moves since the beginning of the year, including the formation in March of a multi-lateral work group for mergers in the...
July 8, 2021
The United States Court of Appeals for the Ninth Circuit has set forth a key ruling in Dan Abrams Co. v. Medtronic Inc.; reasserting an important precedent for off-label use and creating a wrinkle in...
July 7, 2021
The Centers for Medicare & Medicaid Services has suspended the Medicare Coverage of Innovative Technology (MCIT) program through at least the end of the year, and possibly permanently. However, there...
June 28, 2021
Controversies over Diagnostics Renewed The diagnostic test played a vitally important role during the COVID-19 pandemic, but controversy has followed in vitro diagnostics nonetheless. The question of...
June 17, 2021
The FDA has issued final guidance for testing and labeling medical devices for safety in the magnetic resonance environment. This guidance will be essential for manufacturers of both implantable...
June 2, 2021
CMS Adds Administrator, Hits Pause on MCIT The Center for Medicare & Medicaid Services has a new administrator, Chiquita Brooks-LaSure, signaling an end to a leadership void at an agency that is...
May 17, 2021
The FDA has provided an overview of the impact of the COVID-19 on its inspectional regime for drugs, devices and biologics, which seriously impeded inspections of all but top priority manufacturing...
May 4, 2021
The U.S. Supreme Court has ruled in a case involving the Federal Trade Commission regarding limits to the agency’s statutory authority to obtain restitution from defendants in a range of enforcement...
April 20, 2021
The FDA has withdrawn a Jan. 15, 2021, rule by the Department of Health and Human Services that had would have exempted more than 80 medium-risk device types from premarket notification requirements...
