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 » ANDAs Lacking QbD Elements Will Sit in 180-Day Review Queue: MAPP
ANDAs Lacking QbD Elements Will Sit in 180-Day Review Queue: MAPP
October 9, 2012
ANDAs that lack basic quality-by-design (QbD) elements will be categorized as requiring “major” amendments and more extensive FDA consideration, according to a new Manual of Policies and Procedures (MAPP) for reviewers in CDER’s Office of Generic Drugs (OGD).