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Parallel Track

The New Drug Development Process.

Another mechanism to permit wider availability of experimental agents is the "parallel track" policy (Federal Register of May 21, 1990) developed by the U.S. Public Health Service in response to AIDS. Under this policy, patients with AIDS whose condition prevents them from participating in controlled clinical trials can receive investigational drugs shown in preliminary studies to be promising.




Source: U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook.


Back to The New Drug Development Process

 
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