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About this guideline
Adopted by the TGA: 28 February 2020
Overseas publication date: 1 March 2019
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 21 December 2020.
For more information see International scientific guidelines adopted in Australia.