Search


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...
Sharan Murugan
Aug 11, 20242 min read
29 views
0 comments


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)...
Sharan Murugan
Nov 11, 20232 min read
25 views
0 comments


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...
Sharan Murugan
Jun 20, 20231 min read
20 views
0 comments


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,...
Sharan Murugan
Nov 4, 20221 min read
20 views
0 comments


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:...
Sharan Murugan
Oct 17, 20221 min read
26 views
0 comments