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JD Supra: Non-Lab Diagnostics: FDA Regulatory Considerations
JD Supra· 14 hours agoCompanies considering entering the over-the-counter (OTC) diagnostic test space should fully understand their regulatory obligations.
JD Supra: Your Digital Health Regulation Questions Answered
JD Supra· 12 hours agoWondering how the FDA will regulate your digital health or software product? A new navigator tool can help determine the FDA’s potential oversight. The ...
The FDA doesn’t want you to buy anti-choking devices. Here’s why
ClickOnDetroit· 20 hours agoThe devices are not approved or cleared by the FDA. The FDA is concerned that using an anti-choking...
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...
New York Restricts Sale of Weight-Loss and Muscle-Building Supplements to Minors
Insurance Journal· 31 minutes agoThe U.S. Food and Drug Administration oversees the market, but it doesn’t test products before...
Neurocrine bags FDA approval for new ‘sprinkle’ Ingrezza formulation
Pharmaceutical Technology via Yahoo Finance· 5 days agoThe US Food and Drug Administration (FDA) has approved an alternative formulation for Neurocrine...
A decades-old FDA rule is keeping Americans from having better sunscreen
NBC Universal via AOL· 2 days agoThe FDA's ability to approve the chemical filters in sunscreens that are sold in other countries is...
JD Supra: FDA AI & Medical Products Paper advocates for a tailored risk-based regulatory framework
JD Supra· 1 day 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
An FDA Overreaction to Theranos's Implosion Would Harm Patients
Scientific American· 2 days agoSuch laboratory developed tests (LDTs), which are created and utilized within individual...
FDA issues final rule regulating LDTs as medical devices
Medical Device Network via Yahoo Finance· 6 days agoThe FDA ruling follows years of industry back and forth and sees the government body choosing to...