Abstract The Federal Policy for the Protection of Human Subjects, generally referred to as
the “Common Rule,” is the basis for the human research protection policies of 16 signatory …

On July 10, 2015, the US House of Representatives overwhelmingly voted (344–77) to
approve the 21st Century Cures Act, setting the stage for the Senate to consider its own …

Despite more than a century of evolving federal legislation, there remain many unapproved
drugs on the United States (US) market. This article reviews the history of drug approval in …

In September 2016, the Food and Drug Administration (FDA) controversially approved
Exondys 51 (eteplirsen) for the treatment of Duchenne muscular dystrophy (DMD) …

December 2016. Praised by its advocates as a means of speedingdrugdevelopment,
theactcoversseveralareas, but the provisions related to the US Food and Drug …

The twentieth century witnessed significant and continuous advances in medical product
innovation, with breakthroughs in pharmaceutical, engineering and bioscience fields that …

The new drug approval process administered by the Food and Drug Admin istration (FDA) is
in a perpetual state of evolution. And I would suggest that all of us who have an interest in …

ASK ANY TEN PEOPLE in the street whether terminal patients, destined to die, and beyond
the assistance of any known treatment, should be allowed access to investigational drugs …

Within the US Food and Drug Administration (FDA), the Center for Devices and Radiological
Health (CDRH) has primary responsibility for the premarket review and postmarket …

Do terminally ill patients who have exhausted all other available, government-approved
treatment options have a constitutional right to experimental treatment that may prolong their …