Press Release
☷FDA Roundup March 15 2024
Food and Drug Administration ( By Press Release office)
Mar 17,2024
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Also , the FDA Commissioner , Robert M . Califf , wrote a blog post on the potential of artificial intelligence . He talks about how the agency has been getting ready for this for years and how they ' re already receiving lots of submissions for AI - related drugs and devices . They ' re even looking into using AI for their own operations . The blog post links to the new paper too . Lastly , the FDA has updated their guidance on feedback and meetings for medical device submissions . They ' ve set some new goals for providing feedback and they ' re also working on a revised draft guidance . They ' re really committed to keeping things up to date . In other news , the FDA decided to revoke some old standards for frozen cherry pie . They say it ' s not necessary anymore and it ' ll give companies more flexibility to innovate . They ' re also advising restaurants and retailers about a recall of oysters from Connecticut that might be contaminated with norovirus . Oh , and mark your calendars! The FDA is hosting a town hall on medical device sterilization . It ' s happening on March 21st , so don ' t miss it . That ' s all for now , folks . Stay tuned for more updates from the FDA . On Thursday , the FDA gave the green light to Breyanzi ( lisocabtagene maraleucel ) , a gene therapy that uses cells to treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma that has come back or hasn ' t responded to other treatments . Breyanzi , a type of CAR T cell therapy , was already approved for treating certain types of lymphoma . Patients who receive CAR T cell therapy should be monitored for the rest of their lives for new cancers . If a new cancer is found after treatment , contact the manufacturer to report it and get instructions on testing for the CAR transgene . This approval happened quickly under a special pathway .
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