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FDA Approvals - 2010 FDA Approvals and a Look Ahead Recent history can


2010 FDA Approvals and a Look Ahead
Recent history can help us handicap FDA decisions.

FDA To Require Substantial Equivalence Reviews For New Tobacco Products
The U.S. Food and Drug Administration announced that certain tobacco products introduced or changed after Feb. 15, 2007 must be reviewed by the agency. In FDA guidance published this week, the agency outlines a pathway for marketing a product whereby the company marketing the product must prove that it is "substantially equivalent" to products commercially available on Feb. 15, 2007...

FDA drug approvals slow down in 2010 (Morning Read)
Among today's current medical news: FDA approvals decline; American medical tourists remain a rare breed; a cystic fibrosis drug gets troubling news while a low-testosterone treatment moves forward; Vivo Ventures is raising a $350 million fund; and Wisconsin becomes the latest healthcare reform challenger.
 

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