Two months after the FDA issued a safety alert on Pfizer's Chantix, the company in January agreed to update labeling to warn patients about the potential for serious neuropsychiatric symptoms.
The Food and Drug Administration regulates more than a third of the U.S. economy. And its new commissioner, Scott Gottlieb, is trying to shake up how it does so.
Pharma companies are likely to put up aggressive resistance to the measure, introduced earlier this month.
The pace may even pick up again this year.
