FDA Roundup: May 28, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• On Friday, the FDA announced it had opened a new period for applications for grants to support the development and potential approval or conditional approval of new animal drugs intended to treat uncommon diseases (minor uses) in major species (horses, dogs, cats, cattle, pigs, turkeys and chickens) or to treat minor species (MUMS drugs). The maximum individual award amount is $250,000 per year per awardee, for up to two years for routine studies ($500,000 total) and up to three years for toxicology studies ($750,000 total). Grant amount and availability is always dependent upon available funding. Only animal drug sponsors with Designated MUMS animal drugs or their research partners are eligible to apply.
• On Friday, the FDA the FDA posted a new video in the “FDA In Your Day” series. In this video, Principal Deputy Commissioner Dr. Namandjé Bumpus discusses clinical trials day, a webinar on The Real Cost c Friday, the FDA the FDA provided clearance in response to a premarket notification received from Intuitive Surgical for a labeling modification for its previously cleared da Vinci Xi (IS4000) and X (IS4200) Surgical Systems, which are robotic-assisted surgical devices (RASD). The labeling modification describes real-world evidence (RWE) used to support the use of the device in radical prostatectomy (removal of the prostate gland). Collection and analysis of this RWE was conducted by the National Evaluation System for health Technology (NEST) and its strategic partners in close collaboration with Intuitive Surgical and the FDA. This project demonstrates that the NEST system can provide RWE to support premarket regulatory decisions for medical devices.

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