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Cheese recall update as FDA issues highest level of concern
Newsweek· 2 days agoThe U.S. Food and Drug Administration (FDA) recently warned consumers that a brand of cheese...
Lab industry sues to stop FDA’s new LDT rule
MedTech Dive via Yahoo Finance· 19 hours agoVan Meter said the FDA’s plan to use its enforcement authority to regulate tests developed from the present onward “strongly suggests that the agency...
Small Business - The Roanoke-Chowan News-Herald | The Roanoke-Chowan News-Herald
Roanoke-Chowan News-Herald· 2 hours agoThe US Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License ...
FDA’s Delayed Menthol Cigarette Ban Puts Focus on Local Laws
Bloomberg Law· 22 hours agoThe FDA’s stalled effort to ban menthol cigarettes and flavored cigars is shifting attention to states, where health groups and the tobacco industry are jockeying for influence ...
FDA finalizes guidance on “Remanufacturing” vs “Servicing” | JD Supra
JD Supra· 1 day agoIn June 2021, FDA issued draft guidance on “Remanufacturing of Medical Devices,” aiming to help clarify the point when manipulation or repair of a medical device becomes “ ...
Accelerated Approval Process Is Not Without Risk: Placing RecentFDA Action in Context | JD Supra
JD Supra· 3 days agoOn February 23, the Food and Drug Administration (FDA) withdrew approval of Pepaxto (melphalan flufenamide), a drug that it had previously granted accelerated approval for ...
Will FDA's LDT Final Rule Bring "Balance to the (IVD) Force"? | JD Supra
JD Supra· 3 days agoThis action follows FDA's Proposed Rule issued on October 3, 2023 (88 FR 68006, Oct. 3, 2023). Unfortunately, the calendar prevented publication in the ...
Designating a Platform Technology: FDA’s Long-Awaited Draft Guidance | JD Supra
JD Supra· 1 day agoIn newly released Draft Guidance from the U.S. Food and Drug Administration (FDA) entitled, Platform Technology Designation Program for Drug Development, the FDA& ...
FDA monitoring plastic syringe supply chain
Politico· 7 days agoCavazzoni noted the FDA said last week that advisory committee meetings will be held in-person going forward. The closely watched meetings of independent experts...Roe v.
How Long Does it Take For Metformin to Work For Weight Loss?
MediaFeed via AOL· 20 hours agoWhen you’re motivated to lose weight and taking steps to make it happen, you want results — fast....