Agency is also taking new steps to support development of over-the-counter and additional generics of naloxone to help reduce opioid overdose deaths, increase access to emergency treatment
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The Food and Drug Administration oversees manufacturers’ postmark surveillance studies on new and significant health concerns in order to understand a device’s risks and to update policies on such risks.
Encourages Florida Policymakers to Consider Alternatives to Rising Out-of-Pocket Costs
A labeling change order was issued to Sprout Pharmaceuticals last week by the Food and Drug Administration concerning its drug Addyi (flibanserin).
Taking a dietary supplement – like vitamins, minerals, or herbs – has become a daily routine for many Americans.
The U.S. Food and Drug Administration ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the U.S. immediately.
Class 2 Device Recall Stockert/Sorin HeaterCooler System 3T
Statement from Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, on agency efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility
Class 3 Device Recall Micro Knife 5.0mm 30
Class 1 Device Recall o_two e700 Automatic Transport Ventilator
Class 2 Device Recall Biomet RingLoc Hip System SelfTapping Bone Screw
Aleve PM is the first and only over-the-counter (OTC) PM product with the 12-hour pain-relieving strength of Aleve plus a sleep aid. Each caplet combines the sleep aid diphenhydramine HCl (25 mg) with the pain reliever naproxen sodium (220 mg), a nonsteroidal anti-inflammatory drug, to provide relief from occasional sleeplessness associated with minor aches and pains. It can help you fall asleep and stay asleep.
INFUGEM™ (gemcitabine in sodium chloride injection) is the first and only chemotherapy product in a premixed, ready-to-infuse formulation
Statement by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, on new opioid analgesic labeling changes to give providers better information for how to properly taper patients who are physically dependent on opioids
The FDA gave 510(k) medical device designation to Scientific Analytics (SAI) for DARI Health, a computer-vision-powered motion analysis technology.
The FDA has cleared a new treatment for major depressive disorder.
The U.S. Food and Drug Administration announced it is making available online the adverse event reports related to animal drugs and medical devices used in animals.
EAS Consulting Group, LLC, leaders in FDA regulatory consulting services is pleased to announce the expansion of capabilities and comprehensive services offered to clients seeking to file a Generally Recognized as Safe (GRAS) and other submissions documenting food safety to the U.S. Food and Drug Administration (FDA).
Sclerosol Intrapleural Aerosol is currently in shortage
Nelarabine (Arranon) Injection is currently in shortage