Former FDA commissioners: FDARA will change drug development

09/19/2007 | RPM Report (free registration), The

Two former FDA commissioners see the FDA Revitalization Act as having enormous impact on the drug development process when it is passed. Mark McClellan said the bill will move Phase IV control away from pharma companies to a public-private surveillance system. David Kessler say the bill will lead to faster NDA/BLA approvals for drugs with narrow applications, possibly allowing for smaller trials based on genotyping and a target of smaller patient populations.

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RPM Report (free registration), The

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