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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...
A decades-old FDA rule is keeping Americans from having better sunscreen
NBC Universal via AOL· 20 hours 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· 19 hours agoSuch laboratory developed tests (LDTs), which are created and utilized within individual...
JD Supra: FDA AI & Medical Products Paper advocates for a tailored risk-based regulatory framework
JD Supra· 13 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
Philip Morris International Just Reported Zyn-tastic Q1 Results. Can Zyn Propel the Stock Higher?
Motley Fool via Yahoo Finance· 8 minutes agoWhile the product is being sold in the U.S., it is still currently being reviewed by the Federal...
JD Supra: FDA Issues Supplemental Draft Guidance for Premarket Cybersecurity
JD Supra· 14 hours agoThe U.S. Food and Drug Administration (FDA) recently released its draft guidance with a proposal to add a Section VII. The FDA’s draft guidance on Section ...
FDA, doctors warn about compounded Ozempic
WFTV via Yahoo News· 4 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...
FDA Roundup: May 03, 2024
CW39 NewsFix· 2 days agoToday, the FDA announced the availability of draft guidance for industry (GFI) #290 (VICH GL61) entitled "Pharmaceutical Development" for veterinary drug products. This draft ...
Chemo can be brutal. This FDA effort aims to make it less so.
Washington Post· 20 hours agoThe FDA has begun requiring companies to pinpoint the right dosage before cancer drugs reach...
FDA Makes Good on Its Promise to Regulate Laboratory-Developed Tests
The National Law Review· 4 days agoYesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and...