Similar to drug master files, MMFs would allow models to be reused, but critical issues, such as protection of proprietary information, still must be resolved.
Creators of clinical trial modeling and simulation approaches soon could have a pathway for multiple sponsors to use them, potentially streamlining drug development time and costs.
Officials in the US Food and Drug Administration’s Office of Generic Drugs are considering creating model master files, which would...
Generative artificial intelligence tools, such as ChatGPT, have “democratized” AI, and contract research organizations are wholeheartedly embracing these tools, given their focus on efficiency, says Stephen Pyke, who chairs the AI committee at the Association of Clinical Research Organizations.
The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.
Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.
The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.
Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.
Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.
Companies have until early November to respond to a public consultation from the European Commission on its planned Biotech Act, which it hopes will help unleash the potential of small and midsize enterprises in the bloc.
