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A FOOD AND DRUG Administration (FDA) committee has endorsed in principle the concept of expanding the availability of drugs at an early stage of testing to treat acquired immunodeficiency syndrome (AIDS). The driving forces behind this move include AIDS activist groups and support from such medical leaders as Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases.
In accepting the principle, the FDA committee nevertheless grappled with a long list of potential issues that had to be left for later resolution. The committee recommended that these issues be resolved by another group that will be mandated to oversee the process of getting the idea off the ground. Among these issues are the following:
Even though drugs may be made available during phase I testing, it is necessary to ensure that properly controlled clinical trials to determine efficacy will not be compromised.
Some evidence must exist that
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