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FDAAA Impact Analysis: Year One

This article was originally published in RPM Report

Executive Summary

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.

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Post-Marketing Progress: Drug Industry Is Meeting Phase IV Commitments, FDA Says

FDA’s John Jenkins disputes accusations that the pharmaceutical industry does not take post-marketing studies seriously and that the agency is lax on enforcement. According to updated data from FDA, Phase IV studies are being completed in a timely manner, Jenkins argues – and when they aren’t, the agency is taking action.

FDAAA Impact Analysis (Year 3): REMS R.I.P.? Not Yet

FDA’s reconsideration of its new Risk Evaluation & Mitigation Strategy authority put the brakes on use of the new post-marketing safety tools as 2011 began, and a formal decision not to require REMS for all products with mandatory MedGuides means a significant step down in use of REMS in the future. But that doesn’t mean REMS won’t be routine in the future.

REMS 2.0: FDA Refining New Drug Safety Tools

FDA’s new post-marketing risk management authorities are receiving much more public attention in the context of the Avandia decision…but use of the REMS is actually declining. As FDAAA turns 3, it is clear that REMS are going through some growing pains. The new tools will be refined—but they are definitely here to stay.

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