White Paper

The Role Of Real World Evidence To Support US FDA And TGA Registrations

Source: Novotech
fda

Real world evidence (RWE) can contribute valuable information to new medicine registrations, in particular for diseases that are difficult to assess in randomized clinical trials (RCTs) and for emerging technologies such as gene and cell therapies to help enhance our understanding of such products.

Regulatory agencies worldwide are considering how they may incorporate RWE into their decision making processes for new medicine applications.

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Novotech