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USFDA Guidance: Cancer Clinical Trial Eligibility Criterias

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence, Center for Drug Evaluation and Research, and Center for...

USFDA Guidance: Submitting Patient-Reported Outcome Data, Clinical Trial Datasets & Documentation

Today (06 November, 2023) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) released two final...

USFDA Guidance: Selective Approach to Safety Data Collection & Dosing Regimens of PD1 & PD-L1

Earlier today USFDA's Center for Drug Evaluation and Research (CDER) & Oncology Center of Excellence released the updated final guidance...

Draft Guidance on PK-Based Criteria for Alternative Dosing Regimens for Treatment of Cancer - USFDA

On 25th August 2021, the Oncology Center of Excellence along with the Center for Drug Evaluation and Research released new draft guidance...

Guidance on Metastasis-Free Survival as an Endpoint - Prostate Cancer trials – USFDA

USFDA on 06-July-2021, finalized guidance on the use of metastasis-free survival (MFS) as an endpoint in clinical trials for...