Latest news with #FoodAndDrugAdministration
CNA
3 days ago
- Business
- CNA
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.
Reuters
3 days ago
- Business
- Reuters
US FDA launches AI tool to reduce time taken for scientific reviews
June 2 (Reuters) - 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.
NHK
23-05-2025
- Health
- NHK
Taiwan lifts cattle age restriction on beef imports from Japan
Taiwan has lifted restrictions on beef imports from Japan by eliminating the 30-month age limit for cattle. Taiwan's Food and Drug Administration announced the revision to import regulations on Thursday, with the change taking immediate effect. Taiwan banned all imports of Japanese beef after Japan reported an outbreak of BSE, or mad cow disease, in 2001. The ban was partially lifted after safety was confirmed in 2017, allowing imports of beef from cattle no more than 30 months old. Under the latest revision, Taiwan will continue to require the removal of specific parts, such as the brain and spinal cord. But the lifting of the age restriction is expected to expand the market for Japanese beef.
Reuters
20-05-2025
- Health
- Reuters
US FDA advisers to consider if new COVID shots should target LP.8.1 subvariant
May 20 (Reuters) - Advisers to the U.S. Food and Drug Administration will discuss whether to recommend COVID-19 vaccines for 2025-26 for targetting the LP.8.1 subvariant, documents filed on Tuesday showed. The panel of advisers will make recommendations on the selection of the 2025-2026 formula for COVID-19 vaccines for use in the United States on Thursday.
Washington Post
15-05-2025
- Business
- Washington Post
FDA to issue new vaccine approval guidance amid questions over coronavirus shots
The head of the Food and Drug Administration said the agency will soon unveil a new framework detailing what companies must do to seek approval of vaccines, a move that comes as the Trump administration has introduced uncertainty into the annual process for green-lighting updated coronavirus shots traditionally offered in the fall.
