Bradley Merrill Thompson

Ironically, the agency that goes after companies for false and misleading claims is making them about its own policies.

FDA Comissioner Dr. Scott Gottlieb announced a new Digital Health Innovation Action Plan, Pre-Cert Test Plan for 2019 and a Working Model. 

Epstein Becker & Green's Bradley Merrill Thompson says the FDA's much-touted program is riddled with unseen costs and unanswered questions.

This morning, the FDA published its 17-page first draft of a working model for its pre-certification program for software as a medical device (SaMD).

by Bradley Merrill Thompson Let’s say no one had ever invented the tongue depressor, but this year, in a flash of inspiration, I came up with the idea.

By Bradley Merrill Thompson Healthcare in America needs disrupting.

Days after the FDA issued new draft guidance that may be softer on devices making certain kinds of medical claims, the FTC has reminded companies that it also has regulatory power over health claims and might be stepping up to the plate.

Bradley Merrill Thompson testifying before Congress last year.