If you are looking for evidence that the regulatory climate has improved at FDA since 2007, look no farther than FDA's handling of Vivus' weight loss drug Qnexa: FDA's review team was ready to take a risk on the drug despite a number of safety signals that would most likely have killed a product three years ago. But if you want to know how fundamentally the regulatory model has changed, listen to what the committee said in rejecting the application.

If you are looking for evidence that the regulatory climate has improved at FDA since 2007, look no farther than FDA's handling of Vivus' weight loss drug Qnexa: FDA's review team was ready to take a risk on the drug despite a number of safety signals that would most likely have killed a product three years ago. But if you want to know how fundamentally the regulatory model has changed, listen to what the committee said in rejecting the application.

Ironwood Pharmaceuticals and Anthera Pharmaceuticals tested the public offering market in early 2010. The two companies share a positive reading on a thaw in the freeze on public financings, but they show different attitudes on the nature of the regulatory climate. To Ironwood, past regualtory difficulties for other companies are an opportunity. Ironwood does not see much of a threat from new FDA safety tools. Anthera sees the threat but says it has a plan to navigate the new authorities.