“FDA's talented reviewers have been creative and proactive in deploying AI capabilities—agentic AI will give them a powerful tool to streamline their work and help them ensure the safety and efficacy ...
In today’s ACT Brief, we examine how the FDA’s CNPV Program is reshaping operational planning and accelerated submission ...
Explore the challenges sponsors and CROs face in maintaining clinical reference data, uncover the hidden costs of traditional upkeep models, and see how integrated data solutions can streamline ...
In this Q&A, John Kirk, principal regulatory specialist at Veristat, explains how the FDA’s Commissioner’s National Priority ...
In today’s ACT Brief, we examine how the CRA role is transforming alongside modern clinical trial technology, review the ...
The FDA has granted accelerated approval to Otsuka’s Voyxact for adults with primary IgAN at risk of disease progression, ...
Novo Nordisk's 7.2 mg Wegovy injectable aims to enhance chronic weight management in adults with obesity, using an expedited ...
The FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) for the treatment of adult ...
With the right technology and support, CRAs can continue their evolution into powerful agents of trial success that bridge ...
In today’s ACT Brief, we examine how AI is being integrated into administrative workflows at investigative sites, highlight the FDA’s approval of the first gene therapy for adolescents and adults with ...
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