FDA Regulations Target Expanded Access To INDs

The US FDA has finalised new regulations aimed at improving access to experimental drugs for patients with serious or immediately life-threatening diseases who have no comparable or satisfactory alternative treatment options. The two new rules - to be put into effect in October 2009 - clarify how patients can receive access to investigational new drug (INDs) outside of clinical trials and amends regulations about how drugmakers can recoup the costs of providing

To read the full article, please choose one of the following options: