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FDA Roundup: May 10, 2024
WDTN-TV 2 Dayton· 7 hours agoOn Thursday, the FDA provided information on how to safely charge hearing aids, glucose monitors, insulin pumps, and other medical devices to avoid overheating. Medical devices ...
FDA Issues Final Rule to Regulate Laboratory-Developed Tests as Medical Devices
The National Law Review· 11 hours agoOn May 6, 2024, the U.S. Food and Drug Administration published its anticipated final rule...
FDA issues warning on Getinge device amid quality concerns
Medical Device Network via Yahoo Finance· 2 days agoThis action allows additional FDA oversight, an independent auditor, inspections, and updates on...
No evidence Tyson Foods received FDA approval to add insects to human food | Fact check
USA TODAY via Yahoo News· 11 hours agoJohn R. Tyson, the company's chief financial officer, told CNN in October 2023, it is "focused on more of (an) ingredient application with insect protein than we are a consumer application." ...
PharmaTher Announces Assigned FDA Approval Goal Date of its Priority Original Abbreviated New Drug...
Digital Journal· 15 hours agoFood and Drug Administration (the “FDA”) and assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024. As announced by the Company on April ...
FDA partners with other agencies to outline new plan for biotech product regulation
FierceBiotech· 2 days agoThe U.S. FDA, the Environmental Protection Agency and the Department of Agriculture have answered the Biden administration’s call to design a plan to overhaul biotech < ...
FDA Issues Final Guidance to Clarify "Remanufacturing" of Devices that Need Maintenance or Repair
WRBL Columbus· 2 days agoThe final guidance was issued following the agency's extensive review of postmarket information and consideration...to high-quality, safe and effective medical devices," said Jeff Shuren, M.D ...
FDA Finalizes Rule Regulating Laboratory Developed Tests
The National Law Review· 4 days agoFDA’s Final Rule regulating Laboratory-Developed Tests (LDTs) has been published in the Federal...
Califf wants adcomms revamped. Not everyone agrees.
Politico· 11 hours agoSTAT’s Helen Branswell dives into why H5N1 has continued to surprise public health experts since it emerged 27 years ago. The Department of Justice announced it is forming an antitrust division ...
Abortion Pill Cases Test Whether FDA Rules Preempt State Limits
Bloomberg Law· 4 days agoA federal appeals court must weigh how far FDA abortion pill regulations go in preempting state laws regulating the practice of medicine—a largely untested ...
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