Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products - Guidance for Industry

About this guideline

Adopted by the TGA: 24 May 2026

Overseas effective date: 30 August 2023

Replaces: Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products - guidance for industry

Categories: FDA | Real World Data/Real World Evidence (RWD/RWE)

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 27 September 2024.

For more information see International scientific guidelines adopted in Australia