Policy & Medicine - Legal, Regulatory, and Compliance Issues

The European Medicines Agency (EMA)—Europe’s counterpart to the U.S. Food and Drug Administration (FDA)—recently issued…

A significant part of the health care reform debate and subsequent legislation and implementing regulations is how America can…

In 2011, an Institute of Medicine report found that chronic pain affects 116 million Americans and costs the U.S. as…

Over the past few years, this website has been dedicated to highlighting the importance of ethical, physician-industry…

On April 28, 2008, the Food and Drug Administration (FDA) amended its regulations on the acceptance of foreign clinical studies…

Pharmaceuticals have improved and extended the lives of millions of people. But the many advances over the past couple of decades…

As numerous healthcare stakeholders wait for the Supreme Court to determine whether the individual mandate of the Affordable Care…

Former Food and Drug Administration (FDA) Commissioner Andrew von Eschenbach, M.D., recently wrote an op-ed in the Wall Street…

“For decades individual pharmaceutical companies have researched, developed, and donated medicines to fight disease and improve…

Recently Merck agreed to pay $950 million and pleaded guilty to a criminal charge over the marketing and sales of the painkiller…