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Technology & Science

Apr. 6, 2011

Approval Process Gets Tougher for Biotechs

The odds of a new drug or medical device winning U.S. Food and Drug Administration approval are not good and, some say, are getting worse.


By Mandy Jackson


Daily Journal Staff Writer


The odds of a new drug or medical device winning U.S. Food and Drug Administration approval are not good and, some say, are getting worse.


As a result, lawyers say the legal and financial stakes are high and rising for companies whose wagers on FDA approval don't pay off. The agency's unpredictability is causing investors to place fewer bets on biotechnology companies and shareholder lawsuits...

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