BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products
By Zachary Brennan -
Published 17 April 2017
Industry groups BIO and AdvaMed are seeking some changes to the US Food and Drug Administration’s (FDA) guidance on requesting informal input on combination product designations.
Categories: News, US, CBER, CDER, CDRH, Biologics and biotechnology, Combination products, Drugs, In vitro diagnostics, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy
Tags: BIO, AdvaMed, combination product guidance, pre-RFD program