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FDA Issues Final Rule to Regulate Laboratory-Developed Tests as Medical Devices
The National Law Review· 2 hours agoOn May 6, 2024, the U.S. Food and Drug Administration published its anticipated final rule...
FDA delays decision on Moderna RSV vaccine
BioPharma Dive via Yahoo Finance· 6 hours agoThe regulator cited “administrative constraints,” rather than any issue with Moderna’s trial data, for missing a May 12 deadline, the company said.
FDA issues recall statement on insulin pump app after glitch causes more than 200 injuries
USA Today· 6 hours agoThis is a Class 1 recall, which the FDA says is the most serious type of recall, and use of the...
Pharma Stock Roundup: PFE DMD Study Patient Death, FDA Panel Meet for LLY's Donanemab
Zacks via Yahoo Finance· 2 hours agoPfizer (PFE) reports the death of a participant in a mid-stage study of its Duchenne drug. An FDA...
4C Medical’s AltaValve gains dual breakthrough designations from FDA
Medical Device Network via Yahoo Finance· 1 day ago4C Medical Technologies has secured dual breakthrough device designations from the US Food and Drug...
Moderna Stock Seesaws After The FDA Throws It A Curveball
Investor's Business Daily· 3 hours agoThe FDA was due to make a decision by May 12. Moderna emphasized the FDA has not said it found any...
FDA posts final guidance on remanufacturing medical devices
MedTech Dive via Yahoo Finance· 7 hours agoNearly three years after publishing draft guidance, the FDA has changed the title and added a...
Califf wants adcomms revamped. Not everyone agrees.
Politico· 2 hours agoWHAT’S IN A VOTE? In recent days, FDA Commissioner Robert Califf has repeatedly made the case that conducting fewer advisory committee votes would result in more fulsome discussions ...
Feds to spend millions to contain bird flu outbreak amid testing lag
Politico via Yahoo News· 9 minutes agoVilsack said that USDA plans to be a “supportive partner” with the FDA and the CDC, encouraging producers to follow worker safety and biosecurity guidelines, and helping to ...
FDA Issues Reminder for Medical Device Manufacturers to Ensure Data Reliability | JD Supra
JD Supra· 11 hours agoThe U.S. Food and Drug Administration (FDA or agency) recently issued a reminder to medical device manufacturers and sponsors regarding the use of third-party-generated data ...
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