Strong relational governance between technology vendors and sponsor–CRO teams is becoming a critical foundation for eCOA ...
In today’s ACT Brief, we look at how AI and in-silico methods are reshaping drug repurposing, why staggered ICH GCP rollouts ...
ACT: As new ICH GCP guidelines roll out, how are sponsors balancing the drive for innovation—especially in areas like CAR-T ...
In today’s ACT Brief, we look at what’s fueling rapid growth in CNS and autoimmune research, why former FDA leaders are ...
Chen: Yes, obesity is experiencing accelerated growth over the last couple of years. According to our sister product Evaluate ...
The FDA has launched a secure, GovCloud-based agentic AI system to support regulatory workflows across review divisions, ...
For industry-sponsored trials in autoimmune inflammation therapeutic areas, the dominating indications include atopic ...
In today’s ACT Brief, we look at new insights on strategy-driven clinical development, fresh survey data revealing persistent ...
In today’s ACT Brief, we examine how the FDA’s CNPV Program is reshaping operational planning and accelerated submission ...
Examine the rise of personalized and biomarker-driven therapies, the logistical challenges of rare patient populations, and ...
Former FDA Commissioners Warn New Vaccine Policies Could Undermine Longstanding Regulatory Framework
In their NEJM commentary, the former FDA heads stated, “We are deeply concerned by sweeping new FDA assertions about vaccine safety and proposals that would undermine a regulatory model designed to ...
AI-driven discovery, EHR-based real-world evidence, and synthetic patient modeling are rapidly reshaping drug repurposing, reducing development timelines, expanding therapeutic applications, and ...
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