Module232025

12/05/2025

FAIR – The six-point approach

Abolish the 18 year dogma from early drug development

The proposal is a six-point approach in order to improve access for adolescents to new anti-cancer drugs and to make the drug development process more efficient.

Source: ACCELERATE_6 point approach.pdf

The Organisation for Professionals in Regulatory Affairs

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M Dehlinger-Kremer, 14 May 2025

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The FAIR Investigator/Sponsor Toolkit

• Represents a resource provided by the

ACCELERATE platform to support the inclusion of

adolescents in clinical trials. • It offers guidance and tools for investigators and sponsors to design age inclusive trials

https://www.accelerate-platform.org/fair-toolkit

The Organisation for Professionals in Regulatory Affairs

36

M Dehlinger-Kremer, 14 May 2025

36