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The FDA doesn’t want you to buy anti-choking devices. Here’s why
ClickOnDetroit· 4 hours agoThe devices are not approved or cleared by the FDA. The FDA is concerned that using an anti-choking...
Labcorp gains FDA approval for hemophilia B diagnostic test By Investing.com
Investing.com· 3 days agoLabcorp (NYSE: LH) has announced the FDA approval of its nAbCyte Anti-AAVRh74var HB-FE Assay, a...
A decades-old FDA rule is keeping Americans from having better sunscreen
NBC Universal via AOL· 1 day agoThe FDA's ability to approve the chemical filters in sunscreens that are sold in other countries is...
An FDA Overreaction to Theranos's Implosion Would Harm Patients
Scientific American· 1 day agoSuch laboratory developed tests (LDTs), which are created and utilized within individual...
FDA Issues Final Rule Regulating Many Laboratory-Developed Tests as Medical Devices
The National Law Review· 4 days agoOn April 29, 2024, the US Food and Drug Administration (FDA) issued the long-awaited final rule...
FDA Releases Final Rule on Regulation of Laboratory-Developed Tests
GenomeWeb News· 6 days agoThe rule makes explicit that LDTs are in vitro diagnostics and as such are subject to oversight by...
FDA Once Again Stands Athwart Biomedical Innovation, Yelling 'Stop!'
Reason.com via AOL· 6 days agoGrandbrothers | Dreamstime.com As earlier threatened, the Food and Drug Administration (FDA) has...
JD Supra: FDA AI & Medical Products Paper advocates for a tailored risk-based regulatory framework
JD Supra· 19 hours agoSince 1995, FDA has received 300 submissions for drugs and biological products with AI components and more than 700 submissions for AI-enabled devices, according to
FDA, doctors warn about compounded Ozempic
WFTV via Yahoo News· 5 days agoIt’s a popular drug that millions of people are taking to lose weight, but the federal government and doctors are warning users about some versions of...
JD Supra: FDA Issues Supplemental Draft Guidance for Premarket Cybersecurity
JD Supra· 20 hours agoThe U.S. Food and Drug Administration (FDA) recently released its draft guidance with a proposal to add a Section VII. The FDA’s draft guidance on Section ...