Evaluating Cancer Drugs in Patients with Central Nervous System Metastases

On 1 July 2021 the FDA published the final guidance for industry.

The purpose of this guidance is to describe FDA’s recommendations for clinical trial designs of cancer drugs or biological products regulated by CDER and CBER that are intended to support product labeling describing the antitumor activity in patients with central nervous system (CNS) metastases from solid tumors originating outside the CNS.

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