US FDA launches AI tool to reduce time taken for scientific reviews
The U.S. Food and Drug Administration said on Monday that it had launched a generative AI tool, Elsa, aimed at improving efficiency across its operations, including scientific reviews.
"Today's rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers," said FDA Commissioner Marty Makary.
The agency said it is already using Elsa to expedite clinical protocol reviews, shorten the time needed for scientific evaluations, and pinpoint high-priority inspection targets.
Once the FDA receives an application for a potential drug approval, it has six to 10 months to make a decision.
Elsa assists with reading, writing, and summarizing tasks. It can summarize adverse events to support safety profile assessments of drugs and rapidly compare packaging inserts.
"Elsa offers a secure platform for FDA employees to access internal documents while ensuring all information remains within the agency. The models do not train on data submitted by regulated industry, safeguarding the sensitive research and data handled by FDA staff," the FDA said.
In May, the regulator said it would fully integrate AI by June 30, following an experimental run.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
CNA
2 hours ago
- CNA
Boeing president Brendan Nelson on US tariffs, China's aviation market
Boeing said it is operating in what it considers the most complex environment it's seen since World War II — from record demand for commercial jets and defence platforms, to strains in the supply chain, and geopolitical headwinds. President of Boeing Global, Mr Brendan Nelson, shared why he's still bullish on aviation, despite tariff threats. Roland Lim reports.
CNA
2 hours ago
- CNA
Thrive-backed accounting firm Crete to spend $500 million in AI roll-up
-Crete Professionals Alliance, an accounting platform backed by Thrive Capital, plans to invest over $500 million to acquire U.S.-based accounting firms in the next two years, and equip them with OpenAI-powered artificial intelligence technology to boost efficiency, company executives told Reuters. Crete PA is the latest example of how venture capital firms are going after traditional industries and funding a buying spree to transform local businesses with AI in a roll-up play, from healthcare to property management. Founded in 2023, the company has grown to over $300 million in annual revenue with over 20 accounting businesses, making it one of the fastest-growing accounting firms in the U.S. Crete now has 900 employees across 17 offices, and operations in Asia. The firm has raised a few hundred million from investors such as Thrive, ZBS Partners and Bessemer Venture Partners. It plans to use its cash flow and external capital to fund more roll-ups, through which it acquires majority stakes in local firms and supports them with recruiting and administrative work. Jake Sloane, co-founder of Crete PA and ZBS Partner, has previously built roll-up businesses from veterinary to plumbing. Believing AI tools could help accountants expand their customer base and take on more workloads, he partnered with Thrive to take advantage of the tech investor's expertise and network in May 2024. Since then, Thrive, known for its big bets in Silicon Valley companies such as Stripe, OpenAI and Databricks, has its in-house tech team working with OpenAI to build customized tools and models for the accounting industry, from data mapping and memo writing. Bennie Lewis, President at Assurance Dimensions, one of Crete-owned accounting firms in Tampa, Florida, said that in audit testing, the AI tools saved his team hundreds of hours every month, freeing them up for more client-facing work. Sloane said the roll-up diverges from the traditional private equity approach in allowing accounting practices to maintain a minority equity stake in the local business, ensuring original shareholders remain actively involved. Traditional services like accounting have become a hotbed for venture capital investment, which is typically known for ambitious bets on nascent startups in Silicon Valley. Kareem Zaki, a partner at Thrive, said it takes more than selling the software to create value in a complex industry like accounting, so the fund decided to pursue roll-ups that give it more ownership and control of the businesses. "As full-stack operators of the accounting firm, we can take all the software elements, the operational elements, and be able to flow that through into the end customer experience," Zaki said. Sloane said the goal is not to replace accountants with AI, but to use technology to enhance service quality, while humans build trusted relationships. "I don't believe AI is something that will fundamentally eradicate the need for accountants," Sloane said. The industry has faced challenges such as an accountant shortage. Technology has played a significant role in enhancing productivity in the past, such as software tools like QuickBooks. Thrive Capital is not alone in pursuing roll-ups of services in the hope of AI automation. General Catalyst, another VC firm, is also creating firms that buy companies in professional services, including its accounting firm Accrual. Those investors believe generative AI technology can boost profitability and scalability for service businesses, especially those reliant on knowledge work. While accounting firms have been popular targets for private equity, analysts say it will take time to see if they can deliver the higher returns expected for venture capital investments on the heels of AI automation.
CNA
3 hours ago
- CNA
Trump says China's Xi is 'extremely hard to make a deal with'
A fading likelihood of a quick and easy trade deal between the world's two biggest economies, after US President Donald Trump expressed frustration with China. In a Truth Social post, Mr Trump stressed that his Chinese counterpart Xi Jinping was "very tough and extremely hard to make a deal with". The US president had also earlier accused Beijing of violating an agreement reached in mid-May to roll back tariffs and trade restrictions. Kate Fisher reports from Washington DC.
