BioCentury
ARTICLE | Regulation

Last chance on LABAs

FDA ordered safety studies for asthma drugs could be hugely expensive

March 22, 2010 7:00 AM UTC

Although it's not yet possible to determine the final cost of potentially huge post-marketing studies to evaluate the safety of LABAs to treat asthma, it's clear they will not be cheap and will take resources away from other drug development programs.

Even so, the regulatory and political dynamics suggest that the three pharma companies with LABAs on the market will move forward with the studies - the first such trials FDA is requiring under new authorities granted by the FDA Amendments act of 2009 (FDAAA)...