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 » First Month of GDUFA II Sees Large Spike in Generic CRLs
First Month of GDUFA II Sees Large Spike in Generic CRLs
In the first month of the GDUFA II program, the FDA sent 325 complete response letters to generics manufacturers — far more than the high of 190 seen in August the fiscal year before.