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Data Standards for Drug and Biological Product Submissions Containing Real-World Data Guidance for Industry

We have adopted this International Scientific Guideline - Real-World Data/Real-World Evidence (RWD/RWE)

About this guideline

Adopted by the TGA: 13 March 2025

Overseas effective date: December 2023

Replaces: Data standards for drug and biological product submissions containing real-world data – Draft guidance for industry (Adopted by the TGA 27 February 2023)

Categories: FDA | Miscellaneous | 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.
  • This 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.

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