Search
USFDA Request for Information: AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program
Artificial Intelligence (AI) is rapidly transforming drug development by enabling more efficient data analysis, predictive modelling, and evidence-based decision-making. Early-phase clinical trials, particularly Phase 1 studies, represent one of the most challenging stages of drug development due to uncertainties surrounding dose selection, patient recruitment, safety monitoring, and progression decisions. Improving the efficiency of these trials has the potential to accelera
Sharan Murugan
Jul 54 min read
USFDA's: FDA’s Commissioner’s National Priority Voucher (CNPV) Pilot Program to Accelerate Life-Changing Medicines
The U.S. Food and Drug Administration (FDA) has launched the " Commissioner’s National Priority Voucher (CNPV) Pilot Program " a...
Sharan Murugan
Jul 23, 20252 min read
UK MHRA News: "AI Airlock" Pioneering Safe Healthcare Innovation in the UK
The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has launched Phase 2 of its AI Airlock programme , supported by a...
Sharan Murugan
Jun 23, 20252 min read
USFDA Announcement: Shortening the Drug Approval Process- Integration of Generative AI by June end & Completion of First AI-Assisted Scientific Review
The U.S. Food and Drug Administration (FDA) has marked a significant milestone in its digital transformation journey by announcing the...
Sharan Murugan
May 13, 20252 min read
USFDA Guidance: Pilot Program Oncology Drug Products & In Vitro Diagnostic Tests
Earlier today (20 June, 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health, Center for Drug...
Sharan Murugan
Jun 20, 20231 min read