While controversy has raged over the Food and Drug Administration's (FDA) handling of drug safety, a lower-profile but equally important debate has centered on the FDA's role in the development and commercialization of the most innovative kinds of new drug treatments for cancer and other conditions that have long defied...

While controversy has raged over the Food and Drug Administration’s (FDA) handling of drug safety, a lower-profile but equally important debate has centered on the FDA’s role in the development and commercialization of the most innovative kinds of new drug treatments for cancer and other conditions that have long defied...

Across-the-board limitations on discovery can restore a measureofsanityto our courtrooms.

Congress must wean the FDA from its misapplied "first, do no harm" principle, which causes far more harm than it prevents.

This book is the first systematic study of the use and effectiveness of the antitrust consent decree in the federal enforcement of antitrust laws.

In the recent case of Abigail Alliance v. von Eschenbach, a divided panel of the United States Court of Appeals for the D.C. Circuit held that the due process clause required the Food and Drug Administration (FDA) to allow terminally ill patients the opportunity to use last-hope drugs that have...