FDA Aims To Improve Medical Device Security
The agency has issued proposed draft recommendations to guide incorporation of cybersecurity protections into medical devices at the time of manufacture.
Diagnosis & Disease Information
FDA Identifies Most Needed Meds to Address Urgent Medical Conditions
This action was in response to an executive order issued on August 6, 2020 aimed at protecting the public against outbreaks of emerging diseases and chemical, biological, radiological, and nuclear threats.
FDA: Emergency Use Authorization Revoked for Chloroquine, Hydroxychloroquine
The FDA has revoked the emergency use authorization for chloroquine phosphate and hydroxychloroquine sulfate based on emerging data suggesting that these agents are unlikely to be effective against COVID-19.
Medicare Part D Spending: Single-Enantiomer Drugs vs Racemic Precursors
Substituting 12 single-enantiomer drugs with their racemic precursors had the potential to result in $16.6 billion of savings, with Medicare beneficiaries potentially saving $1.1 billion in out-of-pocket expense.
The FDA Seeks Your Feedback on New Measure for Fixed-Quantity Blister Packaging for Opioids
The US Food and Drug Administration is seeking feedback from healthcare professionals on its proposal to offer fixed-quantity blister packaging for a select number of opioid medications.
FDA Launches “Remove the Risk” Campaign for Safe Disposal of Unused Opioids
The U.S. Food and Drug Administration is launching on April 25, 2019, its “Remove the Risk” campaign, aimed at promoting the safe disposal of unused opioids.
FDA: Unapproved Genetic Tests Claim to Predict Drug Response
According to the FDA, no data are available to establish the validity of these tests for their intended uses.
FDA to Review Higher Dose Naloxone Injection for Opioid Overdose Treatment
Drug overdoses resulted in approximately 72,000 deaths in the US, according to the CDC.
Investigational Treatment for Farber Disease Gets Fast Track, Rare Pediatric Disease Designations
Enzyvant announced that the Food and Drug Administration (FDA) has granted RVT-801 both Rare Pediatric Disease and Fast Track designations for Farber disease.
FDA Warns Homeopathic Company About Illegal Product Claims
Nutra Pharma Corp. claims that their unapproved homeopathic products can treat addiction and chronic pain from serious conditions such as cancer, diabetes, shingles, and fibromyalgia.
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