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Indica Labs’ HALO AP Dx platform receives FDA 510(k) clearance
Medical Device Network via Yahoo Finance· 10 hours agoIndica Labs has received 510(k) clearance from the US Food and Drug Administration (FDA) for its...
U.S. FDA advisers back approval for Guardant's blood-based cancer test
AOL· 2 hours agoThe panel voted seven-to-two in favor of benefits outweighing risks when using the test called Shield for colorectal cancer (CRC). CRC occurs in about 150,000 patients in the U.S. annually and ...
FDA Approves Biosimilars for Macular Degeneration Treatment
Healthline via AOL· 1 day agoThe FDA approved two interchangeable biosimilars to treat macular degeneration. The biosimilars work...
FDA classifies Hologic’s recall of BioZorb Marker as Class I
Medical Device Network via Yahoo Finance· 10 hours agoThe US Food and Drug Administration (FDA) has classified the recent Hologic BioZorb Marker recall as...
U.S. FDA advisers back approval for Guardant's blood-based cancer test By Reuters
Investing.com· 2 hours agoThe panel voted seven-to-two in favor of benefits outweighing risks when using the test called...
New Covid FLiRT Variants Have the FDA Weighing a Vaccine Update
Bloomberg· 13 hours agoGood morning! It’s Jessica in New York. A new Covid variant is forcing the FDA to reevaluate...
Guardant Health's blood test to detect deadly colon cancer is under review by the FDA
Quartz· 8 hours agoA U.S. Food and Drug Administration (FDA) advisory committee is meeting today to review a new blood...
Will FDA Advisors Look Past Hypoglycemia Risk With Once-Weekly Insulin?
MedPage Today· 2 days agoConcerns over hypoglycemia risk with an investigational once-weekly insulin product in patients with...
Amphastar maintains stock target on AMP-008 FDA approval By Investing.com
Investing.com· 7 hours agoThe product, which is a generic version of Teva's ProAir HFA (albuterol sulfate inhalation aerosol),...
U.S. FDA advisers back approval for Guardant’s blood-based cancer test
KFGO· 1 hour agoBy Puyaan Singh and Leroy Leo (Reuters) -Advisers to the U.S. Food and Drug Administration on...
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