FDA announces CMC review pilot for drugs with expedited development The US Food and Drug Administration (FDA) announced on 31 October a limited chemistry, manufacturing and controls (CMC) development ...
The FDA’s Rare Disease Framework Initiative brings risk-based CMC review and pre-approval inspections into scope for sponsors ...
Rockwell Automation, Inc. (NYSE: ROK), the world's largest company dedicated to industrial automation and digital ...
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As pharmaceutical products become increasingly complex and companies pursue approvals across international markets, CMC regulatory professionals play a critical role in connecting scientific ...
DOVER, Del., Oct. 6, 2026 /PRNewswire/ -- The Digital CMC Consortium today launched as a new industry collaboration uniting ...
Thermo Fisher Scientific (NYSE:TMO) has helped launch the Digital CMC Consortium to advance digital Chemistry, Manufacturing, ...
The initiative will develop digital standards for technology transfer, knowledge sharing and AI-enabled tools across the drug development lifecycle.
The center of gravity in the race to develop new drugs is shifting from discovering candidates to securing manufacturing and chemistry, manufacturing and controls (CMC) capabilities. As advanced ...
The Digital CMC Consortium has launched with backing from Novartis, Thermo Fisher Scientific, Takeda, Rockwell Automation and other industry leaders, aiming to modernise pharmaceutical development ...