FDA Launches New AI Tool
The Food and Drug Administration on June 2 launched a new artificial intelligence (AI) tool.
FDA officials said Elsa, the tool, will help employees 'work more efficiently.'
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Forbes
26 minutes ago
- Forbes
FDA's New AI Tool Cuts Review Time From 3 Days To 6 Minutes
AI at the FDA getty The U.S. Food and Drug Administration announced this week that it deployed a generative AI tool called ELSA (Evidence-based Learning System Assistant), across its organization. After a low-profile pilot that delivered measurable gains, the system is now in use by staff across the agency, several weeks ahead of its original schedule. Dr. Marty Makary, the FDA's commissioner, shared a major outcome. A review task that once took two or three days now takes six minutes. 'Today, we met our goal ahead of schedule and under budget,' said Makary. 'What took one scientific reviewer two to three days [before] The FDA has thousands of reviewers, analysts, and inspectors who deal with massive volumes of unstructured data such as clinical trial documents, safety reports, inspection records. Automating any meaningful portion of that stack creates outsized returns. ELSA helps FDA teams speed up several essential tasks. Staff are already using it to summarize adverse event data for safety assessments, compare drug labels, generate basic code for nonclinical database setup, and identify priority sites for inspections, among other tasks. This last item, using data to rank where inspectors should go, could have a real-world impact on how the FDA oversees the drug and food supply chain and impacts on how the FDA delivers its services. Importantly, however, the tool isn't making autonomous decisions without a human in the loop. The system prepares information so that experts can decide faster. It cuts through the routine, not the judgment. One of the biggest questions about AI systems in the public sector revolves around the use of data and third party AI systems. Makary addressed this directly by saying that 'All information stays within the agency. The AI models are not being trained on data submitted by the industry.' That's a sharp contrast to the AI approaches being taken in the private sector, where many large language models have faced criticism over training on proprietary or user-submitted content. In the enterprise world, this has created mounting demand for "air-gapped" AI solutions that keep data locked inside the company. That makes the FDA's model different from many corporate tools, which often rely on open or external data sources. The agency isn't building a public-facing product. It's building a controlled internal system, one that helps it do its job better. Federal departments have been slow to move past AI experimentation. The Department of Veterans Affairs has started testing predictive tools to manage appointments. The SEC has explored market surveillance AI for years. But few have pushed into full and widespread production. The federal government has thousands of employees processing huge volumes of information, most of it unstructured sitting in documents, files, and even paper. That means AI is being focused most on operational and process-oriented activities. It's shaping up to be a key piece of how agencies process data, make recommendations, and act. Makary put it simply that ELSA is just the beginning for AI adoption within the FDA. 'Today's rollout of ELSA will be the first of many initiatives to come,' he said. 'This is how we'll better serve the American people.'
Yahoo
an hour ago
- Yahoo
FDA Announces Recall on Popular Aldi Product for Undeclared Life-Threatening Allergen
Select boxes of a popular Casa Mamita product sold at Aldi stores in 13 states have been recalled, according to the U.S. Food & Drug Administration (FDA). Aldi's Casa Mamita Churro Bites Filled with Chocolate Hazelnut Cream have been recalled because they may contain an undeclared milk allergen. Casa Mamita Churro Bites Filled with Chocolate Hazelnut Cream sold at Aldi stores in Alabama, Arkansas, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Mississippi, Missouri, North Carolina, South Carolina, and Tennessee are impacted by this recall. The recalled product was sold in a 7.05-ounce cardboard box and has the lot number 01425 and 'Best If Used By' date of July 14, 2025, on the label. You can find product images on the FDA's site. No other Casa Mamita or Aldi products are impacted by this recall. The churro bites were recalled because the product contains milk, but the allergy warning for milk is not printed on the box, which the FDA requires. Camerican International, the maker of the recalled Casa Mamita product, has identified the issue as due to a 'temporary breakdown' in the processing and packaging, which has since been resolved. If you have a milk allergy, you should not consume the product as it can cause serious or life-threatening reactions for those with milk allergies or intolerances. Instead, you can throw it away or return it to your Aldi store for a full refund. As of this writing, there have not been any reports of allergic reactions or illnesses caused by consuming the Casa Mamita Churro Bites Filled with Chocolate Hazelnut Cream. If you don't have a milk allergy, you do not have to do anything regarding this recall. The product was recalled due to a labeling error and not because it is inherently unsafe to eat. For any questions regarding the recall, you can contact Camerican International directly at 1-201-587-0101 or fsqaincidents@ Read the original article on ALLRECIPES
Medscape
2 hours ago
- Medscape
Targeted Therapy Wins Big for BRAF-Mutated Metastatic CRC
The latest results from the BREAKWATER trial have confirmed encorafenib plus cetuximab with chemotherapy as the new first-line standard of care for BRAF V600E-mutant metastatic colorectal cancer (CRC), according to research presented at the American Society of Clinical Oncology (ASCO) 2025 annual meeting. At the interim analysis, encorafenib plus cetuximab with mFOLFOX6 chemotherapy doubled median overall survival compared with the current standard of care — investigators' choice of chemotherapy with or without bevacizumab. In addition, at a median follow-up of 16.8 months, the new treatment regimen led to a significant improvement in median progression-free survival of almost 6 months. This survival finding is 'unprecedented' and 'practice changing' for these patients who historically have a poor prognosis, said lead investigator and presenter Elena Élez, MD, PhD, a gastrointestinal medical oncologist at the Vall d'Hebron University Hospital in Barcelona, Italy. The study was published in The New England Journal of Medicine to coincide with Élez's presentation. BRAF mutations, which occur in up to 12% of patients with metastatic CRC, are associated with poor outcomes. In December 2024, the US Food and Drug Administration (FDA) granted accelerated approval for the BRAF inhibitor encorafenib alongside cetuximab and mFOLFOX6 for patients with metastatic CRC and a BRAF V600E mutation. This approval was based on earlier results from BREAKWATER that showed a 21% higher objective response rate and a longer duration of response with this regimen. The accelerated approval means that this regimen has already been making its way into the clinic, but 'we were all waiting for this [latest] data,' Pamela Kunz, MD, chief of Gastrointestinal Medical Oncology at Yale University in New Haven, Connecticut, told Medscape Medical News . The doubling of overall survival 'is a big deal,' she said. In the trial, patients were randomly assigned to receive either first-line encorafenib plus cetuximab with mFOLFOX6 (n = 236) or to a control group — physician's choice of either mFOLFOX6, FOLFOXIRI, or CAPOX chemotherapy (n = 243). Most patients in the control arm also received the tumor angiogenesis inhibitor bevacizumab. The broad options in the control arm speak to how heterogeneous treatment has been for BRAF V600E-mutant metastatic CRC, said study discussant Andrea Sartore-Bianchi, MD, a medical oncologist at the University of Milan, Milan, Italy. Patients in the trial had received no prior systemic therapy for metastatic disease. Investigators excluded patients with high levels of microsatellite instability because they are candidates for immunotherapy. At a median follow-up of 16.8 months, median progression-free survival was 12.8 months for the encorafenib group compared with 7.1 months for the control group (hazard ratio [HR], 0.53; P < .0001). At a median follow-up of 22 months, overall survival was 30 months in the encorafenib group compared with 15 months in the control group (HR, 0.49; P < .0001). The benefits of the combination were held up in high-risk subgroups, including in patients with liver metastases and those with metastases in three or more organs. With the use of more agents and a longer duration of treatment due to improved efficacy, there was an expected increase in toxicity with the new regimen. The rate of treatment-related grade 3/4 adverse events was 76.3% with encorafenib vs 58.5% with the control regimen. Patients receiving encorafenib also had higher rates of anemia, arthralgia, rash, and pyrexia, but there was no substantial increase in treatment discontinuation. BREAKWATER also included an encorafenib plus cetuximab arm without chemotherapy, but enrollment was stopped early at 158 patients due to possible futility. Still, these patients had as good or numerically better outcomes than the control group, which means the drug combination alone is a valid option for those unable to tolerate chemotherapy, said Élez. 'The results are striking,' said Sartore-Bianchi in his discussion. 'Now that we have the big picture' from BREAKWATER, the combination should be considered the first-line standard of care. Mark A. Lewis, MD, a gastrointestinal medical oncologist at Intermountain Healthcare in Murray, Utah, explained that what usually happens in metastatic CRC is that people are treated with chemotherapy for a bit before oncologists notice the tumor is behaving more aggressively than expected and order a BRAF test. This delay is now 'completely unacceptable,' he told Medscape Medical News . The takeaway from BREAKWATER is that testing must come sooner. To help with BRAF testing, the FDA approved the Qiagen therascreen BRAF V600E RGQ polymerase chain reaction kit. 'As soon as you know patients are BRAF -mutated, you need to play your entire hand' because it will double survival,' said Lewis. 'This absolutely validates a biomarker-informed approach to colon cancer,' similar to what we have in breast cancer. BREAKWATER was funded primarily by Pfizer, maker of encorafenib, with support from Eli Lilly and Merck, who jointly market cetuximab. Élez reported numerous ties to the companies, including research grants, travel funding, honoraria, and/or consultant work. Lewis, Kunz, and Sartore-Bianchi had no relationships with the firms.
