ANDAs Lacking QbD Elements Will Sit In 180-Day Review: MAPP
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).
300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.
Phone (703) 538-7600 - Fax (703) 538-7676 - Toll free (888) 838-5578.
Copyright by FDAnews. All rights reserved. Do not duplicate or redistribute in any form.