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1,251 Results
Type: News
Section: Industry News > Regulatory
Medical Device/Packaging
New Medical Device Corrects Vision After Cataract Surgery
The FDA has just approved a medical device that corrects refractive errors after cataract surgery, eliminating the need for glasses or contacts.
November 27, 2017
Pharmaceuticals
FDA Prioritizes Energy Restoration at Saline Plants in Puerto Rico
To combat a shortage in the United States, the FDA is asking that saline plants in Puerto Rico have power restored before others.
November 24, 2017
Pharmaceuticals
FDA's Gottlieb on Promoting Generic Opioids to Curb Abuse
FDA Commissioner Scott Gottlieb released a statement outlining plans to reduce opioid addiction by limiting unnecessary exposure.
November 22, 2017
Medical Device/Packaging
FDA Approves Medical Device for Opioid Withdrawal
The FDA has cleared a new electronic earpiece that blocks the withdrawal symptoms of opioid addiction, but concerns regarding its effectiveness linger.
November 20, 2017
Materials
FDA Addresses Opioids, Hurricane Relief, Regenerative Meds
Agency approves electric stimulation device to reduce opioid withdrawal symptoms, creates a policy regarding ‘paradigm-changing’ regenerative medicines, and addresses IV fluid shortages following hurricane destruction.
November 17, 2017
Pharmaceuticals
Trump Nominates Alex Azar for HHS Secretary
President Trump picks former Eli Lilly executive to “be a star for better healthcare and lower drug prices!”
November 17, 2017
Pharmaceuticals
Feds Target Pharma Companies for Role in Opioid Crisis
U.S. attorney’s office goes after pharma billionaire for bribing doctors to prescribe his fentanyl-based spray.
November 16, 2017
Pharmaceuticals
FDA Approves First U.S. Drug with Digital Ingestion Tracking
Otsuka Pharmaceutical’s Abilify MyCite for schizophrenia includes an ingestible sensor embedded in the pill that sends a message to a patch worn by the patient, which transmits information to a mobile app, permitting smartphone tracking and communication.
November 14, 2017
Medical Device/Packaging
J&J Unveils ‘Engineering Studio’ to Accelerate Medical Device Development
Center for Device Innovation @ Texas Medical Center enables concept-to-commercialization, including rapid prototyping, to address patient solutions.
November 13, 2017
Pharmaceuticals
Alex M. Azar II Nominated as Next HHS Secretary
President Trump tweets, “He will be a star for better healthcare and lower drug prices!”
November 13, 2017
Pharmaceuticals
Report Predicts Track-and-Trace Will Be a Game Changer
Report assesses the global anti-counterfeit pharmaceutical packaging market between 2016 and 2026.
November 10, 2017
Medical Device/Packaging
Packaging Issue Leads to Recall of 14,200 Electrodes
Cardinal Health recalls infant/child reduced energy defibrillation electrodes due to incorrect artwork on packaging.
November 10, 2017
Traceability/Serialization
Live from HDA Traceability: Most-Asked Question of the Day
Software, grandfathering and barcodes are major points of interest, but does this low-tech question suggest a need for future guidance?
November 9, 2017
Pharmaceuticals
Young Blood Could Improve Alzheimer’s Symptoms
Researchers at Stanford University are exploring the possibility of infusing blood from young donors into patients with Alzheimer’s.
November 6, 2017
Pharmaceuticals
Move Over Stitches, Human Protein Glue is Here
MeTro is a new flexible adhesive made from a modified human protein that’s capable of healing wounds faster and better than current sealants.
October 23, 2017
Medical Device/Packaging
Forget Blood, New Glucose Monitoring System Uses Sensors
The FDA has approved the first continuous glucose monitoring system for adults that works without blood calibration.
October 20, 2017
Nutraceuticals/Dietary
Federal Court Orders Custompax to Cease Manufacturing
The California-based dietary supplement maker was cited for multiple violations of the current good manufacturing practice and regulations.
October 18, 2017
Pharmaceuticals
Scientists Experiment with Snail Venom to Treat Cancer
The cone snail’s lethal venom could have medical applications ranging from treating Parkinson’s to therapies for cancer.
October 17, 2017
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