In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more
7/7/2025
/ Executive Orders ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Imports ,
Manufacturers ,
Manufacturing Facilities ,
New Guidance ,
New Regulations ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Assessment
In recent years, Congress and the U.S. Food and Drug Administration (“FDA”) have sought to reform the accelerated approval process, an expedited development and approval pathway for drugs that provide meaningful therapeutic...more
1/22/2025
/ Clinical Trials ,
Draft Guidance ,
Drug Safety ,
FDA Approval ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Regulatory Requirements
On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence-enabled software...more
12/11/2024
/ Artificial Intelligence ,
Biden Administration ,
Digital Health ,
Executive Orders ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Labeling ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Public Notice ,
Software