Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics

24 March 2023 – the FDA published draft guidance on the pharmacogenomic data submissions. Submit comments by 24 May 2023.

The purpose of this guidance is to provide recommendations to sponsors of anti-cancer drugs or biological products on considerations for designing trials intended to support accelerated approval. The accelerated approval pathway is commonly used for approval of oncology drugs in part due to the serious and life-threatening nature of cancer and because of available surrogate or intermediate clinical endpoints considered reasonably likely to predict clinical benefit.

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