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FDA, doctors warn about compounded Ozempic
WFTV via Yahoo News· 2 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...
FDA Makes Good on Its Promise to Regulate Laboratory-Developed Tests
The National Law Review· 3 days agoYesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and...
FDA finalizes lab test regulations with more flexibility
Politico· 3 days agoThe new requirements, which kick in over the next four years, include a handful of substantial changes from the agency’s initial proposal. Chief among them is a grandfathering clause which means ...
JD Supra: Every Little One, Every Little One: FDA Issues a Warning Letter to a Medical Device...
JD Supra· 16 hours agoThis Bulletin summarizes the issues involved and our observations. FDA inspected the company and issued a Form FDA 483 List of Inspectional Observations ...
Why TG Therapeutics Stock Was Rocketing Higher This Week
Motley Fool via Yahoo Finance· 1 hour agoCombining that with license, milestone, and royalty revenue, the biotech company's top line totaled...
FDA misses own deadline to propose ban on cancer-linked formaldehyde from hair relaxers
NBC NEWS· 2 days agoThe proposal had come after wide-ranging studies found an association between some of the...
FDA Finally Moves to Scrutinize Specialized Health Screenings
ProPublica· 2 days ago“This is a significant step forward,” said Peter Lurie, president and executive director of the...
FDA approves over-the-counter sales of Narcan. But would you know what to do to save a life?
WPXI· 1 day agoMost of the drug overdoses are caused by opioids or fentanyl. In a move that health experts say may...
United Imaging secures FDA clearance for uMR Jupiter 5T MRI system
Medical Device Network via Yahoo Finance· 1 day agoUnited Imaging, a medical imaging and radiotherapy equipment maker, has secured the US Food and Drug...
FDA issues final rule regulating LDTs as medical devices
Medical Device Network via Yahoo Finance· 3 days agoThe FDA ruling follows years of industry back and forth and sees the government body choosing to...