by Naveen kumar | Nov 28, 2024
Drug Approval Process in India: Simplified Steps Getting a new drug approved in India involves multiple steps to ensure safety, effectiveness, and quality. Here’s a simplified overview: 1. Pre-Clinical Testing Laboratory Testing: Conducted on cells and animals to...
by Naveen kumar | Nov 27, 2024
1. What is the New Drug Approval (NDA) process? Answer: The NDA process is the regulatory pathway for approving a new drug for marketing. It ensures the drug is safe, effective, and of high quality for its intended use. In the U.S., the FDA evaluates the data...
by Naveen kumar | Sep 29, 2024
Top Clinical Data Management Interview Questions and Answers for Freshers 1. What is Clinical Data Management (CDM)? Clinical Data Management is the process of collecting, cleaning, and managing data generated from clinical trials. This ensures the data is accurate,...
by Naveen kumar | 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 Naveen kumar | 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...
