The FDA has issued draft guidance to provides recommendations to sponsors and other interested parties on the use of artificial intelligence to produce information or data intended to support regulatory decision making regarding safety, effectiveness, or quality for drugs, stating that the draft guidance, when finalized, will “represent the current thinking of the Food and Drug Administration on this topic.” The FDA noted that the guidance document is “being distributed for comment purposes only” and that comments and suggestions regarding the draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. In morning trading following the publication of the notice, shares of Tempus AI (TEM) are up $2.05, or 5%, to $40.30.
Stay Ahead of the Market:
- Discover outperforming stocks and invest smarter with Top Smart Score Stocks
- Filter, analyze, and streamline your search for investment opportunities using Tipranks' Stock Screener
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on TEM:
- tempus AI Inc Class A call volume above normal and directionally bullish
- Cathie Wood’s ARK Investment bought 348K shares of Tempus AI today
- Cathie Wood’s ARK Investment bought 335.7K shares of Tempus AI today
- Cathie Wood’s ARK Investment bought 317.6K shares of Tempus AI today
- New CMS decision allows Medicare coverage of TempusECG-AF device