Published in Health Business Week, November 17th, 2006
The protocol was submitted to the FDA under the agency's special protocol assessment (SPA) regulations. The SPA process allows for FDA evaluation of a clinical trial protocol that will form the basis of an efficacy claim for a marketing application, and provides a binding agreement that the study design - including patient numbers, clinical endpoints, and analyses - are acceptable to the FDA.
"We are very pleased that the FDA...
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