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LDTs: FDA Rolls Out a Phased Implementation for New Regulatory Requirements
The National Law Review· 4 days agoOn May 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final rule significantly...
Hims & Hers will sell knock-off Ozempic for $199 — and it won’t be approved by FDA
NY Post via Yahoo Finance· 13 hours agoWill these new, cheaper compound versions, which are less regulated and inherently more risky lead...
FDA Withdraws Approval of FGFR Inhibitor for Bile Duct Cancer
MedPage Today· 4 days agoThe FDA has withdrawn the approval of infigratinib (Truseltiq) as a second-line treatment for...
FDA questions safety of Novo Nordisk's long-acting insulin
Becker’s Hospital Review· 1 day agoOn May 24, an FDA advisory committee will meet to discuss the safety profile of Awiqli (insulin icodec), Novo Nordisk's long-lasting insulin, after a study showed the drug ...
FDA approves belimumab autoinjector for pediatric systemic lupus erythematosus
Medical Xpress· 19 hours agoThe U.S. Food and Drug Administration has approved GlaxoSmithKline's 200-mg subcutaneous route of...
No, there isn’t a proposal to ban decaf coffee in the U.S.
WCNC Charlotte· 12 hours agoSeveral recent headlines claim decaf coffee may soon be banned in the United States by the...
It’s Official: Tara Flour Is an Unapproved Food Additive, According to the FDA
Eating Well via Yahoo News· 3 days agoTara flour made headlines in 2022 after hundreds got sick from Daily Harvest crumbles. Now the FDA...
FDA Clarifies Distinction Between Device Remanufacturing and Servicing in Final Guidance | JD Supra
JD Supra· 2 days agoThe FDA issued its final guidance document on Remanufacturing of Medical Devices (Final Guidance) on May 10, 2024 to provide clarification on the difference between device ...
Novo Nordisk's Once-Weekly Insulin Flagged With Risk Of Low Blood Sugar Ahead Of FDA Review
Benzinga via AOL· 2 days agoThe FDA’s Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to meet on May 24 to...
Study identifies groups of people who mistrust the FDA
Endpoints News· 7 days agoThe FDA has work to do to earn the confidence of certain groups of people who do not trust the...