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1,251 Results
Type: News
Section: Industry News > Regulatory
Medical Device/Packaging
SCANDAL: FDA Hides 50k Heart Device Malfunction Reports
An investigation revealed the FDA allowed a faulty implantable heart device to covertly log 50,000 malfunction incidents without action.
May 30, 2019
Sprint Fidelis / Image: iStock
Medical Device/Packaging
FDA Won’t Ban Breast Implants Linked to Cancer
Textured breast implants have been banned in European countries due to concern they cause cancer, but why won’t the FDA follow suit?
May 17, 2019
Textured breast implants / Image: Getty Images
Pharmaceuticals
This Insys Rap Video May Be the Worst Thing to Come out of the Opioid Crisis
Two Insys Therapeutics salesmen created a distasteful rap video to promote sales of Subsys, the drug company’s opioid product.
May 13, 2019
Insys Rap Video / Image: Handout
Pharmaceuticals
FDA Issues Boxed Warning for Rx Sleeping Pills
U.S. drug regulators have applied a strict new warning for sleeping pills in hopes of preventing dangerous behavior.
May 10, 2019
Sleeping pills can alter behavior. / Image: Relativity Media
Pharmaceuticals
Can You Overdose From Handling Fentanyl?
Police claim that they’re overdosing from accidentally touching fentanyl, but doctors say it’s impossible. Who’s right?
May 7, 2019
Seized Fentanyl / Image: Jessica Rinaldi
Regulatory
UDI: FDA Finalizes Guidance for Convenience Kits
The guidance features clarification of concepts, examples and a Q&A section to help manufactures determine when individual components of a kit require labeling.
April 29, 2019
UDI: FDA Finalizes Guidance for Convenience Kits
Pharmaceuticals
FDA’s 5th Blood Pressure Drug Recall of 2019
Risk of contamination has led to several recalls this year, and could lead to blood pressure drug shortages.
April 29, 2019
Blood Pressure Exam / Image: Spencer Platt
Medical Device/Packaging
FDA OKs Marketing for First ADHD Med Device
The FDA has permitted marketing of a prescription-only device to treat attention deficit hyperactivity disorder.
April 25, 2019
The Monarch eTNS System / Image: Medgagdet
Pharmaceuticals
Largest Counterfeit Pill Bust in History!
Three New Jersey men were arrested in connection with over half a million counterfeit prescription tablets.
April 24, 2019
Seized Pills
Medical Device/Packaging
FDA Says to Stop Selling Vaginal Mesh
An increase in ‘adverse events’ linked to surgical mesh used in pelvic procedures prompts action from the FDA.
April 22, 2019
FDA / Image: Andrew Harnik
Regulatory
The FDA Doesn’t Want you Diagnosing Concussions with an App
The FDA is warning the public against using medical devices marketed to help assess, diagnose, or manage head injuries.
April 18, 2019
Concussion App / Image: Getty
Pharmaceuticals
Cancer Vaccine Shows Promise in Clinical Trial
The experimental cancer vaccine teaches the cancer patient’s body to recognize tumors and attack them.
April 16, 2019
Cancer Vaccine / Image: Pixabay
Regulatory
The FDA is Making Rules for AI in Medicine
The Agency announced that it is developing a regulation system for artificial intelligence products used in medicine.
April 10, 2019
AI / Image: Adobe
Cannabis
FDA & FTC Crack Down on CBD False Medical Claims
The FDA and FTC sent warning letters to three CBD companies making false claims about treating diseases like cancer and Alzheimer’s.
April 5, 2019
CBD Dissolving into Water / Image: Stefan Wermuth
Regulatory
Maybe Don’t Give Kids Homeopathic Products That Contain Snake Venom
The FDA is cracking down on homeopathic products intended for children that put them at risk.
April 4, 2019
Snake Venom / Image: Getty
Traceability/Serialization
Live from Interphex: The Human Challenge in Manual Aggregation
Six months after the serialization enforcement date, a new challenge emerges. Staff and processes must be set up to keep rejected product… rejected.
April 2, 2019
While pharmaceutical companies likely won’t see large returns on their investment, they have a unique opportunity to start monitoring metrics such as OEE, product loss, and dwell time
Traceability/Serialization
Nephron Pharmaceuticals Implements Kit Check for Serialization of Prefilled Syringes
Radio-Frequency Identification (RFID) tags are embedded on all prefilled syringe products at the Nephron 503B Outsourcing Facility.
April 1, 2019
Radio-Frequency Identification (RFID) tags are embedded on all prefilled syringe products at the Nephron 503B Outsourcing Facility.
Medical Device/Packaging
Canada Approves First Marijuana Medical Device
Health Canada has approved Resolve Digital’s smart vaporizer for a Medical Device License for cannabis use.
March 29, 2019
Resolve MD Smart Inhaler / Image: Resolve Digital
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