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FDA approves Alecensa as leading-edge adjuvant therapy for ALK-positive lung cancer
Clinical Trials Arena via Yahoo Finance· 3 days agoOn 18 April 2024, the US Food and Drug Administration (FDA) approved Roche’s Alecensa (alectinib),...
FDA says bird flu tests show milk supply is safe
Deseret News via Yahoo News· 3 days agoNor was active avian influenza found in testing of cottage cheese and sour cream, according to Donald A. Prater, acting director of the FDA Center for...
FDA Brings Lab Tests Under Its Oversight
MedPage Today· 6 days agoThe FDA issued its final rule to regulate laboratory-developed tests (LDTs), the agency said Monday. LDTs are in vitro diagnostic products (IVDs)...
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...
FDA brings lab tests under federal oversight in bid to improve accuracy and safety
Journal Gazette & Times-Courier· 5 days agoThe goal is to ensure that new tests for cancer, heart disease, COVID-19, genetic conditions and...
FDA moves to regulate some tests it says may be unreliable
Anchorage Daily News· 5 days agoThe agency says inaccurate results may force patients to unnecessarily start a new treatment or...
JD Supra: FDA's View on Cannabis
JD Supra· 2 days agoThe U.S. Food and Drug Administration (FDA) is continuing to support clinical research for cannabis and psychedelic drug development. On the heels of publishing its first ...
FDA brings lab tests under federal oversight in bid to improve accuracy and safety
NBC NEWS· 6 days agoThe goal is to ensure that new tests for cancer, heart disease, Covid, genetic conditions and many...
FDA finalizes rule to bring lab-developed tests into the regulatory fold
FierceBiotech· 6 days agoThe FDA has finalized its regulatory rule that aims to bring laboratory-developed tests more in-line...
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...