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FDAAA Impact (Year Two): More of Everything

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The second year of the FDAAA-era is over, and FDA is using its new drug safety tools (Risk Evaluation and Mitigation Strategies and mandatory post-marketing studies) more often. Not only are more drugs requiring REMS and mandatory trials, the burden of those programs is increasing

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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 Risk Evaluation and Mitigation Strategies is actually declining. As FDAAA turns three, it is clear that REMS are going through some growing pains. The new tools will be refined, but they are definitely here to stay.

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 Risk Evaluation and Mitigation Strategies is actually declining. As FDAAA turns three, it is clear that REMS are going through some growing pains. The new tools will be refined, but they are definitely here to stay.

Current Class Of Risk Evaluation & Mitigation Strategies

Here is a general outline of the REMS FDA has mandated so far, as well as a listing of drugs where it has been announced that REMS are being developed or drugs with safety issues that could invoke a REMS.

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