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Tag Archives: special protocol assesment
Tips for your Special Protocol Assessment
A number of scientists with greatly different backgrounds can come up with completely different assessments. – Richard Leakey One question that we hear frequently is: Can we apply for a Special Protocol Assessment (SPA) for our Phase 3 trial? The … Continue reading
Posted in FDA
Tagged advisory committees, FDA, guidance, Phase 3, protocol, special protocol assesment
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Special Protocol Assessments – FDA Transparency vs. Corporate Responsibility
One man’s transparency is another’s humiliation. – Gerry Adams Before I get started, let me be clear: Transparency is a good thing. After FDA Commissioner Margaret Hamburg took office on 18 May 2009, she wasted no time in pushing for … Continue reading
Posted in FDA, Industry News
Tagged FDA, guidance, special protocol assesment, transparency
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