FDA, EMA to Conduct Parallel QbD Reviews as Part of Pilot Program
Under a new pilot program, NDAs submitted to the FDA and European Medicines Agency (EMA) with Quality by Design (QbD) components will undergo parallel review from both regulatory agencies.
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.