FDA deploys generative AI tool Elsa to transform agency operations in historic move
Elsa is the regulator's first large-scale foray into generative AI and is being dubbed as a turning point for the agency.
Built in a secure GovCloud environment, the tool gives staff the ability to quickly search and summarize internal documents without compromising sensitive research and data handled by FDA staff.
More than a chatbot, the tool also allows FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process.Importantly, the AI models do not train on information submitted by regulated industries, ensuring the confidentiality of proprietary research.
'Today marks the dawn of the AI era at the FDA with the release of Elsa, AI is no longer a distant promise but a dynamic force enhancing and optimizing the performance and potential of every employee,' the agency's Chief AI Officer, Jeremy Walsh, said.
'As we learn how employees are using the tool, our development team will be able to add capabilities and grow with the needs of employees and the agency.'
The agency said it is already using the tool to speed up clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high-priority inspection targets.
FDA Commissioner Dr. Marty Makary said the launch came ahead of schedule and under budget due to strong collaboration among internal teams.
'Following a very successful pilot program with FDA's scientific reviewers, I set an aggressive timeline to scale AI agency-wide by June 30,' he said. 'Today's rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers.'
Elsa is a large language model–powered AI tool designed to assist with reading, writing, and summarizing. It can summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications.
It is seen as the first step in a broader strategy to embed AI into FDA workflows.
'Prioritizing efficiency and responsibility, the FDA launched Elsa ahead of schedule using an all-center approach. Leaders and technologists across the agency collaborated, demonstrating the FDA's ability to transform its operations through AI,' the agency within the U.S. Department of Health and Human Services said in a release.
As employees use the tool, its developers plan to expand capabilities to meet emerging needs. This includes improving usability, data processing, generative-AI functions, and tailoring outputs to center-specific needs while maintaining strict information security and compliance with FDA policy.
The agency-wide rollout was coordinated by Walsh, the agency's newly-appointed Chief AI Officer, and Sridhar Mantha. Walsh previously led enterprise-scale technology deployments across federal health and intelligence agencies, and Mantha recently led the Office of Business Informatics in CDER.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
The Hill
23 minutes ago
- The Hill
We can't win the fight to end HIV if we cut funding and access to medication
The fight to end HIV in our lifetimes just received a game-changing innovation. In June, the FDA approved Yeztugo (lenacapavir), a groundbreaking HIV prevention treatment that requires just two injections per year — and scored 99 percent effectiveness in trials. This monumental scientific breakthrough is poised to transform the lives of people who have found it hard to keep up with daily oral pre-exposure prophylaxis, providing an option that fits better into their everyday lives. But as exciting as this development is, it could be undermined by the Trump administration's proposal to cut nearly $1 billion from federal HIV prevention programs. Innovations like lenacapavir could be a key tool to ending the epidemic, but only if we have the resources and policy to deliver it directly to those who need them most. Although lenacapavir's efficacy is groundbreaking, access remains another story. With a price tag hovering around $28,000 a year, this medication risks being out of reach for the very communities who need it most. We're still waiting to see how programs managed by Gilead Sciences, which developed the treatments, and the broader insurance markets will step up. And it's not just the cost of the drug itself. It's the labs, the provider visits, the follow-ups — each one a potential roadblock for someone trying to stay safe. Federal leadership is essential to ensuring this new HIV prevention tool reaches the communities who need it most. This includes updating clinical guidelines, funding support services and supporting the infrastructure that makes access possible. Unfortunately, the Trump administration and the Republican majorities in Congress are putting access to lifesaving innovations at risk. The administration's attacks on HIV prevention, including its proposals to eliminate the Centers for Disease Control and Prevention's HIV budget and efforts to dismantle public health systems, threaten progress. The Republican budget reconciliation bill that President Trump signed over the July 4 weekend includes deep cuts to Medicaid — the largest payer for HIV care in the U.S. Without strong federal investment and coordination, expanding access to new tools and ending the HIV epidemic is at serious risk. Despite the real strides we have made in HIV prevention, those of us in the lesbian, gay, and transgender community — especially non-white Southerners in rural areas or navigating poverty — know that not every prevention strategy reaches us, works for us, or is built with us in mind. Our realities demand options that reflect the full truth of who we are and how we live. Lenacapavir offers real, powerful hope, but let's be clear: Science alone won't save us. What will make the difference is equitable and intentional policies that center our communities and a public health infrastructure that doesn't leave us behind. These numbers don't shift on their own. Yes, we have made progress over time. But the hard truth is that Black Americans still account for 43 percent of all new HIV diagnoses in the U.S., despite being just 13 percent of the population. The data is even more stark for Black transgender women: 44 percent are living with HIV, and their lifetime risk remains unacceptably high. And we cannot ignore the geography of this epidemic. The South accounts for 52 percent of all new HIV diagnoses in the U.S. That's not a coincidence — it is the result of systemic failures: limited access to healthcare, persistent stigma, lack of comprehensive sex education and the absence of strong non-discrimination protections. These barriers don't just prevent care — they trap people in cycles where prevention tools are out of reach. Among gay and bisexual Black men, the risk of contracting HIV is still 50 percent over a lifetime. Prevention tools like pre-exposure prophylaxis and lenacapavir hold promise, but they only matter if people can actually access them, without fear, shame or coercion. Ending this epidemic means creating environments where people are safe to make informed choices about their own health. The fight to end the HIV epidemic is not just about what happens in labs — it's about how we make these innovations real for our communities. Science is doing its part. Now is the time to urge Congress to reject any cuts to CDC HIV prevention efforts and to fully fund the HIV response. We have the tools to end this epidemic, but not if we dismantle the very systems our communities rely on to survive. The promise of lenacapavir, and the hope it represents, is too great to let fall through the cracks of policy neglect. The question is, will we make the choice to ensure that this breakthrough reaches all of us? Science has given us the tools. Now, we must ensure that everyone has the opportunity to use them.
Yahoo
5 hours ago
- Yahoo
12,000 pounds of organic blueberries recalled over Listeria risk — here's what to know
The frozen berries were shipped to a single customer in North Carolina, but the FDA has issued its highest-level health warning. A frozen fruit recall is drawing national attention, but it all comes down to one state. North Carolina is the only area affected by a new FDA blueberry recall, after a batch of frozen organic fruit tested positive for Listeria monocytogenes during finished product testing. The fruit came from Alma Pak International, a Georgia-based supplier, and was shipped on or before June 9, 2025, to a single commercial customer. The FDA has since elevated the recall to Class I — the agency's highest risk category for products that pose a serious health threat if consumed. What's the Recall? Here are the details of the recall so that you can check for affected product in foodservice settings or repackaged goods. Alma Pak Organic Blueberries (frozen) Shipped in 30-pound bulk boxes Lot numbers: 13325 G1060 and 13325 G1096 The recalled blueberries were shipped to a single commercial customer in North Carolina. The FDA has not issued a consumer-facing press release, and the buyer has not been named. These berries were not sold directly to consumers, but could potentially have been used in food service, commercial baking, or other large-batch applications. No other Alma Pak products or lots are included in this recall. Why This Recall Matters Listeria monocytogenes is one of the most dangerous foodborne pathogens, and frozen fruit, while often considered lower risk, has been the source of several high-profile recalls in recent years. Unlike many other bacteria, Listeria can survive freezing temperatures, meaning contaminated fruit remains hazardous even straight from the freezer. While most healthy individuals may experience only mild symptoms, Listeria infections can be life-threatening for pregnant people, newborns, older adults, and immunocompromised individuals. This recall is especially concerning because the blueberries were shipped in bulk, unlabeled boxes. While there's no confirmed evidence the product reached consumers, it's possible the fruit was used in prepared foods like baked goods, smoothies, or frozen blends sold regionally. The Class I designation is not limited to E. coli or meat contamination. It applies to any situation where the FDA sees a 'reasonable probability' that exposure could cause serious illness, including Listeria, undeclared allergens, and other high-risk threats. What to Do If you operate a foodservice business or grocery in North Carolina, check with your distributor to determine whether the affected lot codes were received. The FDA recommends discarding any impacted product and thoroughly sanitizing any prep surfaces, containers, or equipment that may have come into contact with the berries. If you're a consumer who recently bought bulk or repackaged organic frozen blueberries, especially from a small grocer, farmers market, or co-op, ask whether they source fruit from Alma Pak. If you're not sure, it's safest to throw it out. Even frozen fruit isn't immune from contamination. A Class I recall means the risk is real and worth taking seriously, even in just one state. Solve the daily Crossword
Time Business News
5 hours ago
- Time Business News
Unveiling Confidence: A Guide to Breast Implants in Dubai
In the heart of the Middle East, Dubai has emerged as a global hub for medical tourism, offering world-class facilities and highly skilled professionals in various fields, including cosmetic surgery. Among the most sought-after procedures is breast augmentation, a transformative option for women seeking to enhance their silhouette and boost their self-confidence. For many, the decision to undergo breast augmentation is deeply personal. It might stem from a desire to achieve a more proportionate figure, restore lost volume after pregnancy or weight loss, or simply enhance natural breast size and shape. Dubai's vibrant medical landscape provides a sophisticated environment where these aesthetic goals can be realized with precision and care. When considering breast implants in Dubai, it's essential to understand the basics. Breast implants are medical devices placed under the breast tissue or chest muscle to increase breast size and improve shape. They come in various types, primarily distinguished by their filling material: Saline Implants: These are silicone shells filled with sterile salt water. They offer a uniform feel and can be adjusted in volume during surgery. These are silicone shells filled with sterile salt water. They offer a uniform feel and can be adjusted in volume during surgery. Silicone Implants: These are pre-filled with a silicone gel that closely mimics the feel of natural breast tissue. They are known for their soft, natural feel and are available in various consistencies, including 'gummy bear' implants which are form-stable. Beyond the filling, implants also vary in shape (round or anatomical/teardrop) and texture (smooth or textured), each offering different aesthetic outcomes. The choice of implant type, size, and shape is a crucial decision made in close consultation with your surgeon, considering your body type, aesthetic goals, and lifestyle. Dubai's healthcare sector is strictly regulated by the Dubai Health Authority (DHA), ensuring high standards of safety and quality across all medical procedures, including cosmetic surgery. Clinics and surgeons offering breast augmentation must adhere to stringent guidelines, use FDA-approved implants (or equivalent international approvals), and maintain state-of-the-art facilities. This commitment to patient safety provides a reassuring environment for those considering surgery in the emirate. Breast augmentation surgery is typically performed under general anesthesia and usually takes a few hours. The surgeon makes an incision (commonly in the crease under the breast, around the nipple, or in the armpit) and creates a 'pocket' where the implant will be placed – either above or below the chest muscle. Placing implants under the muscle can sometimes offer a more natural look and feel, especially for slimmer individuals. After surgery, you can expect some swelling, bruising, and discomfort, which can be managed with prescribed pain medication. A special support bra is typically worn to aid in healing and support the new implants. While most patients feel well enough to return to light activities and desk jobs within a week or two, strenuous activities and heavy lifting should be avoided for several weeks. Full recovery and the settling of the breast shape can take a few months. It's important to remember that breast implants are not lifetime devices and may require replacement after 10-15 years, though some can last longer. Regular follow-ups with your surgeon are crucial to monitor the implants' condition and address any concerns. Selecting a qualified and experienced plastic surgeon is paramount to achieving satisfying and safe results. In Dubai, many highly reputable, board-certified plastic surgeons specialize in breast augmentation. When making your choice, consider: Board Certification and Credentials: Ensure your surgeon is certified by a recognized plastic surgery board. Ensure your surgeon is certified by a recognized plastic surgery board. Experience: Look for a surgeon with extensive experience in breast augmentation procedures. Look for a surgeon with extensive experience in breast augmentation procedures. Patient Testimonials and Before-and-After Photos: These can provide insights into a surgeon's aesthetic style and patient satisfaction. These can provide insights into a surgeon's aesthetic style and patient satisfaction. Communication: A good surgeon will listen to your goals, explain the procedure thoroughly, and address all your questions and concerns. Dubai offers a unique blend of luxury, advanced medical technology, and highly skilled professionals, making it an attractive destination for those considering breast implants. With careful research and a thorough understanding of the process, you can embark on a journey to enhanced confidence and a more fulfilling self-image. TIME BUSINESS NEWS
