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Aug 112 min read

USFDA Guidance: Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases

Last Thursday (08 August 2024) the U.S. Food and Drug Administration (FDA) released final guidance aimed at " Optimizing the Dosage of...

Nov 11, 20232 min read

USFDA Guidance: Real-Time Oncology Review (RTOR)

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) released guidance earlier this week (07 November 2023)...

Jun 20, 20231 min read

USFDA Guidance: Pilot Program Oncology Drug Products & In Vitro Diagnostic Tests

Earlier today (20 June, 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health, Center for Drug...

Nov 4, 20221 min read

USFDA Guidance: Multiple Biologics related Guidance - M10 Bioanalytical Method Validation

This week USFDAs Center for Biologics Evaluation and Research updated and released multiple guidances related to Gene therapy, Oncology,...

Oct 17, 20221 min read

USFDA Guidance: Multiple Guidances related to Oncology

USFDA's Oncology Center of Excellence released multiple guidances related to Oncology earlier today (17-Oct-2022). Guidance on:...