Boston, MA -- (SBWIRE) -- 08/21/2012 -- The US regulatory environment for generic drugs evolved in a number of ways over 2011 and early 2012. Both the Senate and the House of Representatives passed bills that would implement generic user fees as part of wider Prescription Drug User Fee Act (PDUFA) re-authorization. An agreement must still be reached regarding differences between the bills before being signed by President Obama.
- Provides an update of changes to generic regulations that occurred during the second half of 2011 and first half of 2012
- An overview of the impact of these regulatory changes on the generics industry
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With an ongoing need to reduce the deficit, cost-saving measures remain the focus. In particular, several bills seek to accelerate the launch of generic versions of branded products. Proposals range from a ban on pay-for-delay deals to measures that would allow exclusivity to also be shared by later ANDA filers that successfully challenge patents.
Reasons to Get this Report
- Assess the impacts of recent US regulatory changes on generics producers
- See how pay-for-delay deals continue to face regulatory scrutiny
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