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A Transparency Case Study: Horizant Approval for RLS Offers Window Into Complexity of Complete Response Disclosures

This article was originally published in RPM Report

Executive Summary

The rejection of XenoPort’s restless leg syndrome therapy in February 2010 shocked investors, and so did the April 2011 approval of the application after a nifty piece of regulatory re-engineering by the sponsors. Would public release of the CR letter have helped investors handicap the prospects? That seems unlikely in this case.

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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 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.

The REMS Era Begins: FDA Applies Soft Touch With New Drug Safety Tools

Congress gave FDA some tough new tools to regulate drugs in September, but no one could know for sure how FDA would use them. Now there is some actual real world experience to judge by: a half-dozen drugs approved by FDA are subject to either a Risk Evaluation & Mitiagation Strategy or a mandatory post-marketing commitment. So far, the news is good for drug developers.

Biogenerics Are Happening: Slowly, Product-By-Product

FDA's guidance on biogenerics is on the backburner: Congress is showing little interest in pushing the agency towards them. But some follow-on products are already making it to the market.


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