Zdrowie i gospodarka · 18/08/2026

FDA Releases Draft Guidance on Choosing Between ANDA and 505(b)(2) Applications

The Food and Drug Administration (FDA) has released a draft guidance to help pharmaceutical companies decide between submitting an Abbreviated New Drug Application (ANDA) or a 505(b)(2) application to the FDA for marketing approval. The new guidance aims to replace the 2019 version, which was issued in May.