We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » FDA Won’t Budge on Six-Month Stability Data Call for ANDAs
FDA Won’t Budge on Six-Month Stability Data Call for ANDAs
August 30, 2013
In comments on recent FDA stability testing guidance, ANDA filers angled for regulatory flexibility on how much stability data they should file, but the agency would not budge: the FDA expects to see six months of accelerated stability data and six months of long-term stability data.