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Sharan Murugan
- Aug 11
- 2 min
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...
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Sharan Murugan
- Nov 11, 2023
- 2 min
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)...
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Sharan Murugan
- Jun 20, 2023
- 1 min
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...
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Sharan Murugan
- Nov 4, 2022
- 1 min
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,...
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Sharan Murugan
- Oct 17, 2022
- 1 min
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:...
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