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About this guideline
Adopted by the TGA: 27 February 2023
Overseas publication date: July 2018
Categories: FDA | Procedural
TGA annotations:
The general principles of this guideline are adopted. Please note that any references to FDA processes are not applicable in submissions to the TGA.
- Where FDA guidelines adopted in Australia include references to US legislation, the requirements contained in the referenced US legislation are not applicable to the evaluation of medicines by the TGA.
- The pdf version of this document was downloaded and saved from the U.S. Food and Drug Administration (U.S. FDA) site on 1 May 2024.
For more information see International scientific guidelines adopted in Australia.