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FDA once again stands athwart biomedical innovation, yelling 'stop!'
Reason.com· 5 days agoAs earlier threatened, the Food and Drug Administration (FDA) has just issued new rules that will...
FDA brings lab tests under federal oversight in bid to improve accuracy and safety
The Beatrice Daily Sun· 5 days agoThe goal is to ensure that new tests for cancer, heart disease, COVID-19, genetic conditions and...
FDA Issues Much-Anticipated Final Rule on Laboratory Developed Tests | JD Supra
JD Supra· 3 days agoThe final rule amends FDA regulations to make it explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD ...
FDA brings lab tests under federal oversight in bid to improve accuracy and safety
The Globe Gazette· 5 days agoThe goal is to ensure that new tests for cancer, heart disease, COVID-19, genetic conditions and...
FDA brings lab tests under federal oversight in bid to improve accuracy and safety
The Times of Northwest Indiana· 5 days agoMakers of medical tests that have long escaped government oversight will have about four years to...
Is Your Cancer Test Accurate? The FDA Wants to Make Sure
The Wall Street Journal· 5 days ago“The agency cannot stand by while Americans continue to rely on results of these tests without...
FDA misses own deadline to propose ban on cancer-linked formaldehyde from hair relaxers
NBC NEWS· 3 days agoThe proposal had come after wide-ranging studies found an association between some of the...
More Medical Lab Tests Will Soon Face Federal Scrutiny, FDA Says
WFMZ Eastern Pennsylvania and Western New Jersey· 5 days agoLaboratory tests used by millions of Americans are soon to be classified as medical devices, and as...
Opinion | The FDA Will Test You Now
The Wall Street Journal· 2 days agoThe agency makes a power grab to regulate lab tests like medical devices.
FDA finalizes rule to regulate hospital lab tests
Becker’s Hospital Review· 6 days ago"LDTs are being used more widely than ever before — for use in newborn screening, to help predict a person's risk of cancer, or aid in diagnosing heart disease and Alzehiemer's," Robert Califf ...
