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…
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…
Majority of the World’s Population Breathes Polluted Air, Report Finds
A new report from IQAir reveals that most of the world’s population is exposed to unhealthy air, with only 17% of cities meeting the World Health Organization’s (WHO) air pollution…