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Lawsuit Filed Challenging FDA Final Rule Regulating Laboratory Developed Tests | JD Supra
JD Supra· 12 hours agoAs detailed in our prior analysis (here), the final rule amended the FDA’s existing regulations to make explicit the agency’s interpretation that LDTs are “devices” under ...
Cheese recall update as FDA issues highest level of concern
Newsweek· 5 days agoThe U.S. Food and Drug Administration (FDA) recently warned consumers that a brand of cheese...
How Long Does it Take For Metformin to Work For Weight Loss?
MediaFeed via AOL· 4 days agoWhen you’re motivated to lose weight and taking steps to make it happen, you want results — fast....
Government sets new date for Rwanda removals amid High Court challenge
Press Association News via AOL· 7 hours agoThe Rwanda plan is a key plank of Rishi Sunak’s pledge to ‘stop the boats’ (James...
Accelerated Approval Process Is Not Without Risk: Placing RecentFDA Action in Context | JD Supra
JD Supra· 7 days agoOn February 23, the Food and Drug Administration (FDA) withdrew approval of Pepaxto (melphalan flufenamide), a drug that it had previously granted accelerated approval for ...
Lab industry sues to stop FDA’s new LDT rule
MedTech Dive via Yahoo Finance· 4 days agoVan Meter said the FDA’s plan to use its enforcement authority to regulate tests developed from the present onward “strongly suggests that the agency...
Will FDA's LDT Final Rule Bring "Balance to the (IVD) Force"? | JD Supra
JD Supra· 7 days agoThis action follows FDA's Proposed Rule issued on October 3, 2023 (88 FR 68006, Oct. 3, 2023). Unfortunately, the calendar prevented publication in the ...
Chinese firm addressing FDA concerns over Durham facility - Triangle Business Journal
The Business Journals· 6 days agoCARsgen Therapeutics has responded to observations made by the U.S. Food and Drug Administration...
FDA responds to senator’s letter that calls out ‘FDA’s failure to act’ on NOW’s test results
Nutraingredients.com· 3 days agoLast April, South Carolina Congressman Jeff Duncan wrote to FDA Commissioner Dr. Robert Califf,...
JD Supra: FDA Makes Good on Its Promise to Regulate Laboratory-Developed Tests
JD Supra· 3 days agoYesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and highly controversial – final rule, which rolls out a four-year, five-stage ...
