BALTIMORE – To modernize its pharmacovigilance efforts, the US Food and Drug Administration (FDA) Office of Surveillance and Epidemiology (OSE) is using artificial intelligence (AI) to support the ...
BALTIMORE – In an effort to enhance the transparency of Risk Evaluation and Mitigation Strategies (REMS), the US Food and Drug Administration (FDA) has launched a publish an interactive web-based ...
MMS, a global, data-focused clinical research organization (CRO), today announced that Somya Dunn, MD, has joined the company as Senior Medical Director, Safety Risk Management, further advancing the ...
The US FDA can now require companies to develop a risk evaluation and mitigation strategy (REMS) for therapeutic products. Bethan Hughes investigates the recent evolution of risk-management strategies ...