Zdrowie i gospodarka · 05/09/2001

FDA Releases Draft Guidance on Submitting Marketing Applications in ICH/CTD Format

The Food and Drug Administration (FDA) has made available a draft guidance document that outlines general considerations for submitting marketing applications for new drugs, abbreviated new drugs, and biologics, in accordance with the International Conference on Harmonisation (ICH) M4 guidance on organizing the Common Technical Document (CTD) format.