News

US FDA limits industry employees from roles in its advisory committees
U.S. Food and Drug Administration Commissioner Martin Makary announced on Thursday a policy to limit employees of companies ...
BioPharma Dive21h
Makary seeks to limit industry’s role in FDA advisory panels
Commissioner Martin Makary said the agency would, whenever possible, restrict drug company employees from participating as ...
Trump layoffs begin to erode FDA drug review system
The firings this week also include all staff responsible for managing records – such as new product applications – at FDA ...
Pharmaceutical Technology on MSN8d
FDA to phase out animal testing with AI and lab-based models
The FDA has announced plans to phase out animal testing in the development of monoclonal antibodies and other drugs.
Exclusive-FDA fires most negotiators for pharma user fee talks, sources say
The U.S. Food and Drug Administration's mass layoffs included senior negotiators in talks with the pharmaceutical industry over renewing the user fee programs that fund the regulator's drug review ...
STAT21d
Ouster of FDA’s Peter Marks alarms a biopharma industry that saw him as an ally
Jason Mast is a general assignment reporter at STAT focused on the science behind new medicines and the systems and people ... reporting on the crossroads of drug development, business, Wall ...
Forbes23d
Makary’s FDA Has Options In Industry Fight Over Weight Loss Drugs
Forbes contributors publish independent expert analyses and insights. I’m an ER doc, public health researcher and patient advocate.
Manila Standard1mon
FDA goes digital with eServices Portal System
THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device Notification (CMDN) for Class A ...