The Opening Volley in the Drug Safety Debate
This article was originally published in RPM Report
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The RPM Report’s analysis of the fi rst year under FDA’s new law makes one fact clear: sponsors seeking approval for never-before-marketed ingredients need to assume the new tools will apply to them.
Rethinking Phase IV: Congress Wants to Get Tough on Post-Marketing Requirements, but FDA May Soften the Blow
Congress is ready to grant FDA more authority over Phase IV studies-over the objections of both agency officials and drug sponsors. But if FDA is right, improvements to the designs of post-marketing studies may help reduce the impact on industry.
The pharmaceutical industry and FDA are getting ready for a fight-and for once they are on the same side. They want Congress to reauthorize the Prescription Drug User Fee Act quickly and cleanly-without tacking on other reforms to FDA's drug regulations. They probably won't get their wish.