Public/Private Initiative To Help FDA Modernize Guidance For Clinical Trials
Output from the Clinical Trials Transformation Initiative, whose executive board was named May 5, is expected to lead to new FDA clinical trial guidance
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The agency is seeking a quality-by-design approach to clinical trials so sponsors can identify potential risks to patient safety and trial implementation up-front and take steps to avoid them.
The FDA Amendments Act, which reauthorized the user fee program and gave FDA broad new powers to ensure drug safety, has given the agency an abundance of oversight functions to organize, but also has provided the agency an outside partner: The Reagan-Udall Foundation
In an FDA-Duke University Medical Center partnership to modernize the way clinical trials are conducted, close attention will be paid to the increase of outsourcing and off-shoring clinical trials