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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 Roundup: May 10, 2024
FOX 16 Little Rock· 6 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 ...
One year after FDA approves over-the-counter birth control pill, advocates push for more access
West Virginia Watch via Yahoo News· 6 hours ago“My parents are immigrants from India, and it’s been over the counter there since my mom can...
FDA posts final guidance on remanufacturing medical devices
MedTech Dive via Yahoo Finance· 17 hours agoNearly three years after publishing draft guidance, the FDA has changed the title and added a...
JD Supra: FDA Approves New Indication for AstraZeneca and Daiichi Sankyo’s Cancer Drug ENHERTU
JD Supra· 8 hours agoOn April 5, the FDA granted accelerated approval to AstraZeneca and Daiichi Sankyo’s ENHERTU (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2 ...
FDA considers updating blood donation guidelines to keep nation’s supply safe from malaria
CNN via AOL· 1 day agoThe US Food and Drug Administration is considering a requirement for blood banks to use a new test...
FDA Issues Reminder for Medical Device Manufacturers to Ensure Data Reliability | JD Supra
JD Supra· 20 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 ...
Moderna Stock Seesaws After The FDA Throws It A Curveball
Investor's Business Daily· 12 hours agoThe FDA was due to make a decision by May 12. Moderna emphasized the FDA has not said it found any...
Pharma Stock Roundup: PFE DMD Study Patient Death, FDA Panel Meet for LLY's Donanemab
Zacks via Yahoo Finance· 11 hours agoPfizer (PFE) reports the death of a participant in a mid-stage study of its Duchenne drug. An FDA...
FDA issues recall statement on insulin pump app after glitch causes more than 200 injuries
USA Today· 15 hours agoThis is a Class 1 recall, which the FDA says is the most serious type of recall, and use of the...