Research Backlash: Does FDA Have A PMA Problem?
This article was originally published in The Gray Sheet
Executive Summary
In the wake of recent reviews criticizing the quality of pre-market cardiac device trials, FDA, industry, clinicians and others are debating what reforms are necessary to PMA study standards
You may also be interested in...
FDA Guidance Emphasizes Randomized, Blinded Trials For PMAs
Clinical studies in support of pre-market approval applications should ideally be randomized and blinded, FDA maintains in recent guidance.
FDA Guidance Emphasizes Randomized, Blinded Trials For PMAs
Clinical studies in support of pre-market approval applications should ideally be randomized and blinded, FDA maintains in recent guidance.
Relief Efforts To Aid Haitian Amputees Require Long-Term Commitment
Industry and nonprofits that supply assistive devices to amputees are gearing up for a long-term relief effort in Haiti