Certain Tobacco Products To Be Reviewed, Says FDA
Certain tobacco products that came onto the market or were altered after February 15, 2007 will have to be reviewed by the FDA (Food and Drug Administration), the Agency announced as it published a new guidance today. Any company which markets a tobacco product needs to prove that it is "substantially equivalent" to those that were on the market on February 15, 2007. What does "substantially ...

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 ...

Decline in approvals challenges drug firms
A decline in U.S. drug approvals, spurred by an "increased conservatism" on safety issues by the Food and Drug Administration, raises the stakes in 2011 for the nation's largest drugmakers.