International scientific guidelines: Appendix 1 to the guideline on the evaluation of anticancer medicinal products in man Methodological consideration for using progression-free survival (PFS) or disease-free survival (DFS) in confirmatory trials

About this guideline

Overseas effective date: 1 Apr 2014

Categories: Clinical efficacy and safety | Antineoplastic and immunomodulating agents

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Replaces: EMEA/CHMP/EWP/27994/2008 (Adopted by TGA 16 March 2009)

For more information see International scientific guidelines adopted in Australia.

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.