Zdrowie i gospodarka · 13/10/2017

FDA Releases Draft Guidance on Choosing Between ANDA and 505(b)(2) Applications

The Food and Drug Administration (FDA) has published a draft guidance to help pharmaceutical companies decide which abbreviated approval pathway to use when submitting a marketing application to the FDA, with the goal of choosing between an Abbreviated New Drug Application (ANDA) or a 505(b)(2) application.