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JD Supra: FDA AI & Medical Products Paper advocates for a tailored risk-based regulatory framework
JD Supra· 38 minutes 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
Chemo can be brutal. This FDA effort aims to make it less so.
Washington Post· 8 hours agoThe FDA has begun requiring companies to pinpoint the right dosage before cancer drugs reach...
An FDA Overreaction to Theranos's Implosion Would Harm Patients
Scientific American· 7 hours agoSuch laboratory developed tests (LDTs), which are created and utilized within individual...
A decades-old FDA rule is keeping Americans from having better sunscreen
NBC Universal via AOL· 8 hours agoThe FDA's ability to approve the chemical filters in sunscreens that are sold in other countries is...
JD Supra: FDA Issues Supplemental Draft Guidance for Premarket Cybersecurity
JD Supra· 2 hours agoThe U.S. Food and Drug Administration (FDA) recently released its draft guidance with a proposal to add a Section VII. The FDA’s draft guidance on Section ...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 Roundup: May 03, 2024
WFRV 5 Green Bay· 24 hours agoToday, the FDA announced the availability of draft guidance for industry (GFI) #290 (VICH GL61) entitled "Pharmaceutical Development" for veterinary drug products. This draft ...
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...
Continued FDA testing finds no active bird flu virus in variety of dairy products
News Channel Nebraska· 9 hours agoBy Brenda Goodman, CNN
FDA brings lab tests under federal oversight in bid to improve accuracy and safety
WHIO-TV 7 Dayton· 5 days agoThe goal is to ensure that new tests for cancer, heart disease, COVID-19, genetic conditions and...
FDA Says It Will Take on Wider Regulation of Medical Tests. Is It Ready?
Bloomberg· 1 day agoHi, it’s John in Boston. This week, the FDA signaled it may finally make a move that’s been on the...
