CBER will take a page out of the drug center’s book and start issuing shorter guidances more quickly; sponsors should also be on the lookout for an RIF on ways to collaborate with agency.
The Center for Biologics Evaluation & Research wants to publish guidance documents in “real time” and find ways to work more collaboratively with sponsors on fast-moving areas of drug development like cell therapies, while still being able to “hold ourselves accountable” as regulators, CBER Director Peter Marks said.
“We are trying to take a page out of CDER’s book, which is trying to do guidance in much more...
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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.
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.
Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.
