Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

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 18, 20221 min read

Philippines FDA - Guidelines on Abridged and Verification Review Pathways for New Drug Registration

Abridged review refers to a limited independent assessment of specific parts of the dossier, or submission for suitability of use under...