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About this guideline
Adopted by the TGA: 26 June 2024
Overseas publication date: July 2020
Categories: FDA | Clinical/Medical
TGA annotations: Nil
- 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 24 April 2024.
For more information see International scientific guidelines adopted in Australia.