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International scientific guideline: FDA: Submitting documents using RWD and RWE to FDA for drugs and biologics - Guidance for industry

Submitting documents using RWD and RWE to FDA for drugs and biologics – Guidance for Industry adopted by the Goods Administration (TGA)

About this guideline

TGA adopted date: 27 February 2023

Overseas effective date: September 2022

Categories: Procedural

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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.

For more information see International scientific guidelines adopted in Australia.

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.

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