Medical Device and Pharmaceutical News
The latest information of interest to regulated industry. Bookmark this page to have a quick review for
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FDA Approves DATROWAY® Breast Cancer Treatment
A new breast cancer treatment option The United States Food and Drug Administration (FDA) approved DATROWAY® (datopotamab deruxtecan-dlnk) on January 17, 2025, for adults with hormone receptor-positive (HR+), HER2-negative breast cancer that is unresectable or...
A Dangerous and Unapproved Drug Sold as a “Cure”
The dangers of tianeptine FDA warns that tianeptine is sold online and even at gas stations as a supposed treatment for depression, anxiety, pain, and opioid withdrawal. But don’t be fooled — this drug is not approved by the FDA for any medical use in the U.S. and has...
Beware of False “Cures” for Autism
Unapproved and Potentially Harmful Products Autism Spectrum Disorder (ASD) affects about 1 in 68 children, and while early behavioral therapies can help improve symptoms, there is no cure for autism. Unfortunately, some companies promote unproven products that falsely...
Formaldehyde in Hair Smoothing Products: Know the Risks
Know the Risks Before You Straighten Thinking of straightening or smoothing your hair? Many salon hair treatments release formaldehyde gas — a known human carcinogen — when heated. This chemical can pose serious short- and long-term health risks to both clients and...
FDA: Do Not Use OTC Products to Remove Moles or Skin Tags
FDA: Do Not Use OTC Products to Remove Moles or Skin Tags Thinking about removing a mole, skin tag, or other skin lesion at home? The FDA strongly advises against it. There are no FDA-approved prescription or over-the-counter (OTC) products for removing moles,...
FDA Alert: Baxter Recalls Spectrum Infusion Pumps
Baxter Spectrum Infusion Pump Alert Date: July 2025Device: Sigma Spectrum Infusion System (V6 and V8 Platforms)Manufacturer: Baxter HealthcareIssue Type: Urgent Medical Device RecallFDA Status: High-risk; active monitoring in progress The FDA has issued an early alert...
Orthopedics Industry Consolidation
Consolidation in the Implantable Orthopedics Industry: A Historical Perspective Early Growth and Initial Consolidation (Pre-2000s) The orthopedic implant industry experienced significant growth in the late 20th century, driven by advancements in medical technology...
How Unsafe Medical Devices Can Slip Through the Cracks
Healthcare professionals and the device industry share responsibility for timely adverse event reportingGlobal device market withdrawals not always followed in US In a world of global trade and instant communication, you might assume that a medical device deemed...
Study Reveals Delays in Medical Device Adverse Event Reporting
Healthcare professionals and the device industry share responsibility for timely adverse event reportingLapses defeat the purpose of adverse event reporting A recent study published in the British Medical Journal has spotlighted a troubling trend: many medical device...
QMSR Strategy for US Companies with QSR and ISO Compliance
QMSR Implementation Strategy for U.S. Medical Device Manufacturers Compliant with the QSR and ISO 14385:2016 If your company is already compliant with the QSR and ISO 13485:2016, you’re ahead of the curve in the transition to FDA’s Quality Management System Regulation...