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...

Biotech Calendar: FDA Drug Approvals in 2011
BOSTON (TheStreet) -- An early Christmas present for biotech investors: The first (overstuffed) FDA drug approval calendar of 2011. For easy reference, I've organized this regulatory calendar in chronological order based on the drug approval decision date. I've also included information on pending FDA advisory panels. At the end of the calendar is a list of companies with potential regulatory ...

FDA Decision To Revoke Avastin For Breast Cancer Use Remains Topic Of Debate
Physicians, lawmakers and advocates continue to debate FDA's decision last month to revoke approval of Genentech's drug Avastin for breast cancer treatment, USA Today reports. In July, an FDA advisory panel recommended 12-1 that the agency revoke the drug's use for treatment of late stage breast cancer after concluding that the risks of using the drug outweigh the benefits and that it does not ...