Access To Investigational Drugs Remains Challenge Despite New FDA Rules
Executive Summary
FDA has widely publicized ways for patients to get access to investigational trial drugs outside of trials, but there are still many barriers that could hold up implementation in the real world
You may also be interested in...
FDA Expanded Access Guidances Fail To Achieve Détente With Advocates
The number of requests to use investigational drugs outside of clinical trials has grown and FDA typically approves all requests, but advocates still insist the process is set up to fail patients.
Making Expanded Access Programs Work For - Not Against - Your Trial Drug
Providing an investigational drug outside of a controlled trial carries inherent development risks, but it can also be a win-win proposition for patients and sponsors when managed well, veterans of "expanded access" programs say
Making Expanded Access Programs Work For - Not Against - Your Trial Drug
Providing an investigational drug outside of a controlled trial carries inherent development risks, but it can also be a win-win proposition for patients and sponsors when managed well, veterans of "expanded access" programs say