Artificial Intelligence (AI) is revolutionizing healthcare, particularly in the medical device sector. AI-powered software is now integrated into...
Robert F. Kennedy Jr.'s potential influence on the U.S. healthcare regulatory environment could bring significant changes to the approval and...
The FDA has released a draft guidance, Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics, outlining proposed...
Digital health is transforming patient care, diagnostics, and treatment through innovations like mobile health apps, software as a medical device...
The Global Unique Device Identification Database (GUDID) has become a cornerstone of regulatory compliance and supply chain transparency in the...
The Biosimilar User Fee Act (BsUFA) has been a key factor in expediting biosimilar approvals and enhancing regulatory efficiency in the U.S. Under...
The FDA's release of the final guidance on marketing submission recommendations for Predetermined Change Control Plans (PCCPs) in AI-enabled device...
