Digital health is transforming patient care, diagnostics, and treatment through innovations like mobile health apps, software as a medical device...
GUDID Data Trends in 2024: Key Insights for the Medical Device Industry
The Global Unique Device Identification Database (GUDID) has become a cornerstone of regulatory compliance and supply chain transparency in the...
Understanding the BsUFA III Regulatory Science Pilot Program
The Biosimilar User Fee Act (BsUFA) has been a key factor in expediting biosimilar approvals and enhancing regulatory efficiency in the U.S. Under...
FDA Final Guidance: Submissions for PCCP in AI-Enabled Device Software
The FDA's release of the final guidance on marketing submission recommendations for Predetermined Change Control Plans (PCCPs) in AI-enabled device...
Top 5 Keys to Success for Life Science Companies in 2025 and Beyond
The life sciences industry is entering a new era, shaped by rapid advancements in technology, evolving regulatory landscapes, and growing societal...
The Most In-Demand Jobs for Regulatory & Quality Compliance in Life Sciences: 2025 and Beyond
The life sciences industry is evolving rapidly, driven by advances in technology, the globalization of markets, and increasingly complex regulatory...
The Indispensable Role of People: What AI Cannot Do in Regulatory and Quality Compliance in Life Sciences
Artificial Intelligence (AI) has become a transformative tool in the life sciences industry, revolutionizing how Regulatory and Quality Compliance...