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.
The removal of CBER Director Prasad comes after a wave of right-wing backlash to his appointment over the past few days that was also critical of his decision to ask Sarepta to suspend all sales of the DMD gene therapy Elevidys. FDA reversed its decision the day before Parsad's departure.
The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.
Pink Sheet reporter and editors discuss the potential impact George Tidmarsh could have as director of the US FDA Center for Drug Evaluation and Research and the issues threatening the future of Sarepta’s gene therapy Elevidys.
