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.

Scope

- 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

View Full Report Details and Table of Contents

Highlights

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

About Fast Market Research
Fast Market Research is an online aggregator and distributor of market research and business information. Representing the world's top research publishers and analysts, we provide quick and easy access to the best competitive intelligence available. Our unbiased, expert staff will help you find the right research to fit your requirements and your budget. For more information about these or related research reports, please visit our website at http://www.fastmr.com or call us at 1.800.844.8156.

Browse all Pharmaceuticals research reports at Fast Market Research

You may also be interested in these related reports:

- BRIC: Pricing, Reimbursment, and Regulatory Update
- Global LTE Industry Landscape: Adoption, Applications, Deployments and Subscriptions by Region, Country, Spectrum and Operator 2011 - 2015
- Biosimilars: Global Regulatory Update
- Pricing and Reimbursement in Generics - European Austerity Measures and Healthcare Cost Containment Puts Innovation-Driven Pharma Companies under Pressure
- The World Generic Market Report 2012
- Generics in Cardiovascular Diseases Market to 2018 - Loss of Lipitor Market Exclusivities and Impending Patent Expirations of Plavix to Drive Generic Substitution
- Generics in Japan
- Biosimilars Approval Pathways in the US and Europe - Development and Approval of Biosimilar mABs May Face Tough Regulatory Environment
- Pharmaceutical Key Trends 2011 - Healthcare System and Drug Regulatory Overview: Cost-containment and regulatory pressures intensify
- Healthcare, Regulatory and Reimbursement Landscape - Spain