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.
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Keeping guidances in draft form makes Congress angry, but finalizing them gives Wall Street the vapors.
CDER continues to allow most submissions it receives for access to investigational drugs but critics say barriers prevent vast numbers of patients from requesting access.
FDA appears to support the idea behind the bipartisan bill, which would allow the agency to meet with the sponsor early in the development process when a candidate shows substantial improvement over existing therapies and consider expedited trials going forward.