by Dr. Yashashwini Reddy | Sep 19, 2024
Japan Regulatory Authorities for Drug Approval: A Comprehensive Overview Navigating the complex landscape of drug approval in Japan requires a keen understanding of its regulatory authorities and processes. Japan’s commitment to ensuring the safety and efficacy...
by Dr. Yashashwini Reddy | Sep 19, 2024
Japan’s new drug approval process is managed by the Pharmaceuticals and Medical Devices Agency (PMDA), which works under the Ministry of Health, Labour, and Welfare (MHLW). Here’s an overview of how a drug gets approved in Japan: 1. Preclinical Testing...
by Dr. Yashashwini Reddy | Sep 14, 2024
Differences Between New Drug Application (NDA) and Biological License Application (BLA) The New Drug Application (NDA) and the Biological License Application (BLA) are two critical submissions to the U.S. Food and Drug Administration (FDA), but they cater to different...
by Srikanth | Aug 31, 2024
What is Pharmacovigilance? Pharmacovigilance, as defined by the World Health Organization (WHO), refers to the science and activities related to identifying, assessing, comprehending, and preventing adverse reactions or other drug-related problems. Aims of...
by Dr. Yashashwini Reddy | Jul 4, 2024
Clinical Data Management Interview Questions What is annotated CRF? The annotated CRF is a blank case report form with markings or annotations that map clinical data collection fields used to capture subject data to corresponding Variables contained within the SDTM...
