Research and Markets: New Drug Review and Outlook 2011/New Medical Device Review and Outlook 2011 Bundle Package

DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/73eb94/new_drug_review_an) has announced the addition of the "New Drug Review and Outlook 2011/New Medical Device Review and Outlook 2011 Bundle Package" report to their offering.

“New Drug Review and Outlook 2011/New Medical Device Review and Outlook 2011 Bundle Package”

The United States remains the leader for medical devices, accounting for about two-fifths of the worldwide market. An impending overhaul of the U.S. Food and Drug Administration's 510(k) device approval protocols will help dictate the direction of the U.S. market share in the years to come. FDA unveiled a plan consisting of 25 actions the regulatory agency plans to implement in 2011 to improve the most common path to market for medical devices.

The emerging economies of Brazil, Russia, India, and China (BRIC) have transformed into profitable, high-growth medical device markets. These emerging economies are on the rise because of increasing use of medical devices due to growth in health awareness as well as for their offshore business operations and production.

This special report about medical device approvals includes the following information:

A recap and analysis of the promising and anticipated medical devices approved by the U.S. Food and Drug Administration via the Premarket Approval (PMA) process during 2010 and early 2011.

A complete listing of the medical devices cleared for marketing by FDA via the 510(k) Premarket Notification process in 2010, including the following details for each entry:

• Product code
• Product description
• Registration number
• Company
• Decision date

Although new molecular entity approvals in the United States dropped from 26 in 2009 to 21 in 2010, the percentage of NME approvals cleared for marketing versus the number of such filings markedly improved year-over-year. FDA's Center for Drug Evaluation and Research approved 21 out of 23 (91.3%) NME submissions in 2010 as opposed to 26 out of 37 (70.3%) for 2009. Partly due to FDA's continued push for more stringent product-safety standards in recent years, the annual amount of NME approvals from 2005-2010 ranged from the high teens to mid twenties versus 36 in 2004.

New Drug Review and Outlook 2011 is presented in the following four sections.

• Potential Blockbusters
• Products Awaiting FDA Clearance
• FDA's New Medicines of 2010
• U.S. Approvals Over Time

What you will find in this special report

In the first part, analysis is provided regarding some of the most-anticipated products expected to emerge from the late stages of the industry pipeline. The second segment presents a listing of new drugs awaiting first-time FDA approval. The report's third portion contains an overview of the 88 new prescription medicines that were approved via a new drug application (NDA) or biologic license application (BLA) in the United States during 2010. The fourth sector of this report lists in alphabetical order the products that have been approved by FDA via an NDA or BLA since 1990.

*This is a bundle package containing two seperate reports

For more information visit http://www.researchandmarkets.com/research/73eb94/new_drug_review_an