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Supply chain experts said that most manufacturers successfully implemented the enhanced tracing requirements outlined in the Drug Supply Chain Security Act (DSCSA) by the 27 May deadline without ...
Recon: Sarepta resumes shipments of Elevidys for ambulatory patients; Merck to cut costs by $3B Recon | 29 July 2025 | Jason Scott ...
340 Global Regulators, Health Authorities and Industry Partners Gather in Sydney for Australia Regulatory Device Summit 2025 RAPS Announcements | 21 July 2025 | RAPS ...
WASHINGTON @ The US Food and Drug Administration (FDA) plans to make significant updates to its recently launched artificial intelligence (AI) tool Elsa within the next month and has taken critical ...
WASHINGTON @ Marty Makary, commissioner of the US Food and Drug Administration (FDA), said he wants the agency to become nimbler in the next five years to adapt to the fast pace of medical innovation.
The US Food and Drug Administration (FDA) has launched a new artificial intelligence (AI) tool nearly one month ahead of schedule that the agency says significantly improves operations and is aimed at ...
The International Council for Harmonisation (ICH) on Wednesday announced it will develop four new guidelines addressing real-world evidence, comparative efficacy studies, rare disease drug development ...
The US Food and Drug Administration (FDA) is exploring the possibility of changing the fee structure of the Prescription Drug User Fee Act program (PDUFA) to rebuild trust in the agency, said Grace ...
The US Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) are seeking public input on regulations, rules, or guidelines that should be eliminated under ...
The Council for International Organizations of Medical Sciences (CIOMS) has issued a draft report detailing a set of best practices to guide the integration of artificial intelligence in ...
Bipartisan members of the Senate Appropriations Committee expressed concern about potential cuts to federal biomedical research funding and their support for stable funding at the National Institutes ...
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