FDA Approves First Long-Acting Flea and Tick Treatment for Dogs
The U.S. Food and Drug Administration (FDA) has approved Bravecto Quantum, a groundbreaking injectable flea and tick treatment for dogs and puppies aged 6 months and older. This new medication…
Is Botox Safe? A Look at the Risks Behind the Popular Cosmetic Procedure
A recent cluster of at least 10 botulism cases linked to a Massachusetts spa has reignited concerns about the safety of Botox injections, a procedure widely used to reduce wrinkles.…
FDA Issues Warning Letters to Drugmakers Over Unauthorized Marketing and Sterility Violations
The U.S. Food and Drug Administration (FDA) has issued warning letters to three companies for serious regulatory violations. Two manufacturers, PMS4PMS and Naturista Store, were cited for marketing drug products…
Ultrasound imaging…risks/benefits
Understanding Ultrasound Imaging: How It Works, Its Benefits, and Patient Guidance Ultrasound imaging, or sonography, uses high-frequency sound waves to create real-time images of the inside of the body, including…
Warning: Certain Gel Nail Polish Removers Contain Banned Ingredient Methylene Chloride
The FDA has recently found that several cosmetic products marketed as gel nail polish removers contain methylene chloride, a hazardous ingredient prohibited in cosmetics under federal law (21 CFR 700.19).…
Is Independence the Key to Solving the Student Mental Health Crisis?
As mental health issues surge among U.S. children, one nonprofit is offering a surprisingly simple solution: let kids be kids—independently. Lenore Skenazy, author and co-founder of Let Grow, believes that…
How to Report a Problem with a Cosmetic Product
If you’ve had a bad reaction to a cosmetic product—like a rash, burn, or even hair loss—or noticed something off with a product (bad smell, color change, or contamination), it’s…
Study Finds Nearly One-Third of Medical Device Adverse Event Reports Were Late or Incomplete.
A new BMJ-published study has found that nearly 30% of medical device adverse event reports submitted to the FDA’s MAUDE database between September 2019 and December 2022 were either submitted…
FDA Cracks Down on Unauthorized Medical Device Modifications
The FDA has recently issued a Warning Letter to a medical device manufacturer for making unauthorized modifications to a previously cleared device under the 510(k) pathway. In a nod to…
Laser hair removal company cited for cGMP violations.
Laser hair removal company cited for cGMP violationsFDA inspector badges at its headquarters in White Oak, MD. (Source: Ferdous Al-Faruque) The US Food and Drug Administration has warned New Jersey-based…
Warning: Gel Nail Polish Removers Contain Banned Toxic Chemical
The FDA has issued a warning about several gel nail polish remover products that contain methylene chloride, a banned substance in cosmetics under U.S. law (21 CFR 700.19). Methylene chloride…
What is a Pulse Oximeter?
Pulse Oximeter Basics A pulse oximeter, or pulse ox, is a device that estimates the amount of oxygen in the blood. Here’s what to know. Español中文한국의TagalogTiếng Việt We need oxygen…