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
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Expanded Access Programs Need FDA Policy Changes To Really Expand
Agency should issue statement that deaths occurring during compassionate use will not automatically penalize a drug's development, ethicists from NYU Langone Medical Center say.
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.
Sponsors Caution Against Premature Expanded Access For Novel HCV Drugs
Early positive trial results for direct-acting antivirals for Hepatitis C, combined with the seriousness of the disease and unmet clinical need, make Hep C an obvious target for expanded access programs.