Monday, October 8, 2007

Big pharma vs. generics

Are things getting easier for generics? Big pharma can't like this development. The battle between big pharma and generics goes on....

http://www.bloomberg.com/apps/news?pid=20601202&sid=aeXJBnqXjKB4&refer=healthcare

Generic Drugs May Get Faster Review Under New Rules (Update2)
By Catherine Larkin

Oct. 4 (Bloomberg) -- Generic drugs, priced 30 to 80 percent less than their brand-name counterparts, may get faster reviews under new policies designed to handle hundreds of backlogged applications, U.S. regulators said.

The Food and Drug Administration said today that it is bolstering its generic-drug program by giving priority to decisions on products that are the first of their kind, and by giving applicants more feedback. The policies, some already in place, were designed to shorten the queue of more than 1,300 drugs awaiting approval.

....

The new policies include priority reviews for drugs that are the first of their type and aren't subject to litigation. Previously, the agency reviewed applications in the order they were submitted. The FDA is also shifting to electronic data submission and communications and plans to give more feedback to the industry about how applications should be designed.

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