The U.S. Food and Drug Administration is now requiring its strongest warning to be used on several of the most commonly used prescription insomnia medicines.
Seven drugs were recalled in April to protect patients from possible harmful defects associated with the products, the U.S. Food and Drug Administration reported.
U.S. FOOD AND DRUG ADMINISTRATION: Life Rising Corporation Recalls Chinese Herbal Supplements Because of Possible Health Risk
Life Rising Corporation of Willowbrook, IL is recalling Life Rising Holder-W Holder Warmer capsules, Life Rising NECK-ND Neck Clear capsules, and HoliCare Metabolism Cleansing (MET-CLS) tablets because the products have the potential to contain excessive levels of lead.
The Medical Device Safety Action plan outlines the FDA’s mission to protect public health in a more timely and effective way.
The Food and Drug Administration is looking to women aged 35-64 to “Remove the Risk” of opioids in the household.
'Stop doing these analyses,' Mercatus Center researcher says ahead of FDA benefit-risk public meeting
The U.S. Food and Drug administration's public meeting in May about the agency's human drug lifecycle benefit-risk activities has already attracted a recommendation from a regulatory and policy researcher: “stop doing these analyses.”
NEUROSIGMA, INC.: Announces FDA Clearance of Monarch eTNS System as First Non-Drug Treatment for Pediatric ADHD
NeuroSigma, Inc., a Los Angeles-based bioelectronics company focused on commercializing Trigeminal Nerve Stimulation (TNS) technology for treating neurological and neuropsychiatric disorders announced that its Monarch® eTNS® System (Monarch) received FDA clearance as a non-drug treatment for attention deficit hyperactivity disorder (ADHD).
Manufactures of surgical mesh for the transvaginal repair of pelvic organ prolapse (POP) must stop selling their product after an order from the Food and Drug Administration.
Anderson Advanced Ingredients® commends the most recent draft guidance by the U.S. Food and Drug Administration (FDA) titled "The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels".
Food producers carried out 20 food or dietary supplement product recalls over the past two months, according to the U.S. Food and Drug Administration.
U.S. FOOD AND DRUG ADMINISTRATION: FDA issues final rule on safety and effectiveness of consumer hand sanitizers
Action completes a series of actions on the FDA’s review of OTC antiseptic active ingredients
U.S. FOOD AND DRUG ADMINISTRATION: FDA warns public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion
The U.S. Food and Drug Administration is warning the public not to use medical devices marketed to consumers that claim to help assess, diagnose or manage head injury, including concussion, traumatic brain injury (TBI) or mild TBI.
Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration.
U.S. FOOD AND DRUG ADMINISTRATION: FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications
The U.S. Food and Drug Administration issued a warning letter to Inova Genomics Laboratory (Inova) of Falls Church, Virginia, for illegally marketing certain genetic tests that have not been reviewed by the FDA for safety and effectiveness.
Eleven drugs were recalled in March to protect patients from possible harmful defects associated with the products, the U.S. Food and Drug Administration reported.
U.S. FOOD AND DRUG ADMINISTRATION: FDA warns homeopathic firms for putting patients at risk with significant violations of manufacturing quality standards
The U.S. Food and Drug Administration today posted warning letters to four companies who produce homeopathic drug products for significant violations of current good manufacturing practice (CGMP) regulations, including a letter to King Bio Inc. of Asheville, N.C.
Twelve prescription drugs were recalled in January and February to protect patients from possible harmful defects associated with the products, the U.S. Food and Drug Administration reported.