The FDAAA effect
The FDA Amendments Act will cause a fundamental shift toward a greater emphasis on drug safety within FDA, Covington & Burling Partner Richard Kingham suggests. "Inevitably, many provisions of the law, even the transfer of more of the PDUFA registration fee money to the drug safety side of the agency, are going to change the equilibrium in terms of where the emphasis is in the review process and postmarket labeling regulatory control process," he says at the Drug Information Association's pharmacovigilance meeting Jan. 14...
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