BioCentury
ARTICLE | Regulation

Lowdown on LABAs

How FDA uses dose-response curve to evaluate LABAs for pulmonary disorders

September 16, 2013 7:00 AM UTC

Although vilanterol looks poised to pass muster at FDA for a second time, companies working on products that contain a LABA should not view it as a sign the agency is no longer requiring companies to establish the lowest effective dose.

FDA last week told BioCentury it needs to see a well-defined dose-response curve that clearly identifies the lowest dose on the ascending portion of the curve...