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The FDA doesn’t want you to buy anti-choking devices. Here’s why
ClickOnDetroit· 7 hours agoThe devices are not approved or cleared by the FDA. The FDA is concerned that using an anti-choking...
JD Supra: Non-Lab Diagnostics: FDA Regulatory Considerations
JD Supra· 2 hours agoCompanies considering entering the over-the-counter (OTC) diagnostic test space should fully understand their regulatory obligations.
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...
Neurocrine bags FDA approval for new ‘sprinkle’ Ingrezza formulation
Pharmaceutical Technology via Yahoo Finance· 4 days agoThe US Food and Drug Administration (FDA) has approved an alternative formulation for Neurocrine...
JD Supra: FDA AI & Medical Products Paper advocates for a tailored risk-based regulatory framework
JD Supra· 23 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 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, 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JD Supra: FDA Issues Supplemental Draft Guidance for Premarket Cybersecurity
JD Supra· 24 hours agoThe U.S. Food and Drug Administration (FDA) recently released its draft guidance with a proposal to add a Section VII. The FDA’s draft guidance on Section ...