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
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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.
FDA Update: March medical device recalls
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.
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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.
11 drugs recalled during March, FDA reports
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.
12 drugs recalled in first 60 days of 2019, FDA reports
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.
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JANSSEN PHARMACEUTICALS, INC.: Janssen Submits Supplemental New Drug Application to U.S. FDA for INVOKANA® (canagliflozin) for the Treatment of Chronic Kidney Disease in Patients with Type 2 Diabetes
If approved, INVOKANA® will be the first and only therapy in nearly 20 years indicated to reduce the risk of end-stage kidney disease when added to current standard of care
FDA releases statement on new policies to curb youth access to flavored tobacco products
The Food and Drug Administration is looking toward a future where combustible cigarettes are not addictive and do not harm as many people as are currently affected by nicotine and additive chemicals.
FDA Update: January-February medical device recalls
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 Food and Drug Administration.