FDLI

A tough question - but one that FDA, pharmaceutical manufacturers, physicians, patients and the courts now are urgently trying to answer. FDA has proposed rules that will make it easier for dying patients to get access to drugs still undergoing clinical trials. And the U.S. Court of Appeals for the D.C. Circuit is revisiting its landmark decision in Abigail Alliance v. von Eschenbach.

So, how will this issue affect you? You can find out with a copy of this White Paper, published by FDLI as part of its Colloquium Series on important issues affecting the food and drug industry. The White Paper includes insightful articles by Scott Ballenger, who represents Abigail Alliance; Richard Cooper, former FDA general counsel; Scott Gottlieb, former FDA Deputy Commissioner for Medical and Scientific Affairs; nationally recognized ethicist Arthur Caplan; litigator Mark Gately; pharmacist Frank Polumbo and David Welch, founder of 38 Lemon, an organization promoting brain cancer awareness from a patient's perspective.

This is a downloadable PDF product. You will be directed to a download link after purchase. No product will be shipped.