Search results
FDA Issues Final Guidance to Clarify "Remanufacturing" of Devices that Need Maintenance or Repair
WFRV 5 Green Bay· 7 hours agoToday, the U.S. Food and Drug Administration issued final guidance to provide the medical device industry clarity on the definition of "remanufacturing" ...
FDA’s Final LDT Rule Is Here, and the Changes Show the Agency Is Serious and Actually Listening to...
The National Law Review· 3 days agoThe Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs)...
Scientists Are Finding Out Just How Toxic Your Stuff Is
Time via Yahoo News· 37 minutes ago“Oftentimes, that’s very much not true.” Despite its nearly $7 billion annual operating budget, the...
UPDATE 2-US FDA advises healthcare facilities to switch from Getinge's heart devices
Reuters via Yahoo Finance· 1 day agoThe U.S Food and Drug Administration (FDA) on Wednesday advised healthcare facilities to move away from using Getinge's heart devices ...
Is Eli Lilly Stock A Buy Or A Sell As FDA Plans Meeting To Discuss Alzheimer's Drug?
Investor's Business Daily· 4 hours agoThe FDA has signed off on its tirzepatide in patients with type 2 diabetes and as a weight-loss drug...
Nut recall as "life-threatening" warning issued
Newsweek· 6 hours agoA nut recall was issued this week alongside warnings of a possible "life-threatening" allergic reaction. On Wednesday, the U.S. Food and Drug ...
The Major Statement: FDA's Recent Q&A Guidance and...Direct-to-Consumer Prescription Drug...
JD Supra· 3 hours agoOn December 26, 2023, the Food and Drug Administration (FDA) issued a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer ...
Over 200 People with Diabetes Injured After Insulin Pump App Crashes, Drains Battery
People via Yahoo News· 1 hour agoThe Food and Drug Administration (FDA) announced on Wednesday, May 8 that the company Tandem...
Jazz Pharma to Fight FDA in Court Over Rival Sleep Drug Approval
Bloomberg Law· 12 hours ago...pharmaceutical manufacturer known for its sleep medicines will argue Friday before a federal district court that the FDA violated an orphan drug law when it approved a rival product. will take to the US District Court for the District of Columbia to argue its case against the Food and Drug ...
After 200 reported injuries, FDA urges users to update this diabetes health app
Staten Island Advance· 6 hours agoThe U.S. Food and Drug Administration (FDA) is urging consumers to update a health app connected to...
