Medical Devices and Pharma
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FDA Cracks Down on Illegally Marketed 7-OH Products
Unapproved drugs sold online and in retail locations Yesterday the U.S. Food and Drug Administration (FDA) issued seven warning letters to companies marketing products that contain 7-hydroxymitragynine (7-OH) — a powerful and potentially dangerous opioid-like...
Sterile Drug Manufacturing Violations at Daewoo Pharmaceutical
FDA Cracks Down on Sterile Drug Manufacturing Violations The U.S. Food and Drug Administration (FDA) has issued a warning letter to Daewoo Pharmaceutical Co., Ltd. in Busan, South Korea, citing serious and widespread violations of current Good Manufacturing Practices...
What Are Early Recall Alerts?
Recall Communication “Early Alerts” Note: This summary is based on an FDA communication attributed to Michelle Tarver, M.D., Ph.D., director of the Center for Devices and Radiological Health (CDRH). In November 2024 the U.S. Food and Drug Administration’s Center for...
Urgent Recall Alert for BD Alaris Infusion Sets
Class I Recall (Correction) The FDA has issued an early alert to healthcare providers and patients regarding a performance issue affecting BD Alaris Pump Module model 8100, used with specific compatible infusion sets. BD, through its subsidiary CareFusion, has...
When Apparel Becomes a Medical Device
Lessons from FDA’s Breast Binder Warning Letters In December 2025, the FDA issued warning letters to several companies selling breast binders and chest compression garments online. The agency concluded that marketing claims on company websites, like statements about...
Labeling Correction for TRUE METRIX® Blood Glucose Meters
Labeling Correction for TRUE METRIX® Blood Glucose Meters Highlights the Critical Role of Clear Error Messaging Trividia Health, Inc. has initiated a labeling correction affecting all TRUE METRIX®, TRUE METRIX AIR®, TRUE METRIX GO®, and TRUE METRIX PRO® blood glucose...
When a “Good Enough” Design May Fail the User
Advancing from Basic Design to Usability In a world shifting toward user-centered regulation, even the simplest medical devices can demonstrate why human factors and usability engineering matter. The FDA’s Quality Management System Regulation (QMSR) – which aligns...
Ethicon Issues Safety Alert for Surgical Stapler Cartridge
Endopath Echelon Vascular White Reload for Advanced Placement TipSource: FDAUrgent Class I Medical Device Recall Ethicon Endo-Surgery, LLC has issued an urgent correction for its Endopath Echelon Vascular White Reload for Advanced Placement Tip (35 mm, 4-row). This...
The FDA Orphan Drug Program
Incentives for Rare Disease Drug Development The FDA’s Orphan Drug Program was established to encourage the development of drugs for rare diseases that affect fewer than 200,000 people in the U.S. Because these diseases often lack market incentives due to small...
FDA Grants Accelerated Approval to Multiple Myeloma Treatment
For hard-to-treat multiple myeloma On July 2, 2025, the FDA granted accelerated approval to linvoseltamab-gcpt (brand name: Lynozyfic) for adults with relapsed or refractory multiple myeloma who have received at least four prior therapies, including: A proteasome...
FDA Approves Alhemo for Patients with Hemophilia A or B
For Patients with Hemophilia A or B with Inhibitors The FDA has approved Alhemo (concizumab-mtci) for routine prophylaxis to prevent or reduce bleeding episodes in patients aged 12 and older with: Hemophilia A with factor VIII inhibitors, or Hemophilia B with factor...
First-in-Class Non-Opioid Pain Reliever: Journavx
A new non-opioid pain treatment option On January 30, 2025, the FDA granted priority review for Journavx (suzetrigine) – a first-in-class, non-opioid analgesic for treating moderate to severe acute pain in adults. How It Works Journavx targets sodium channels in the...
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Why These Salmonella Outbreaks Keep Happening
Why These Salmonella Outbreaks Keep Happening: “Illness First, Controls Later” An MDP Consumer and Industry Brief When people hear “FDA is investigating,” they often assume the system detected a safety problem early and intervened. In many dietary supplement...
Four Moringa-Linked Salmonella Events in Four Months
Four Moringa-Linked Salmonella Events in Four Months: The Timeline That Should Not Exist An MDP Consumer and Industry Brief A single recall can be dismissed as a one-time failure. Two recalls in the same ingredient category raise questions. But when moringa-based...
Moringa and the “Invisible Outbreak” Problem
Moringa and the “Invisible Outbreak” Problem in Supplements An MDP Consumer and Industry Brief Most Americans assume dietary supplements are monitored for safety in the same way as conventional foods or pharmaceutical products. But many supplement contamination events...
Rosabella Moringa Capsules Potential Salmonella Contamination
Rosabella Moringa Capsules Recalled Over Possible Salmonella Contamination Editor's Note: This February 13 recall is the latest moringa-root product recall, following the Sam's Super Greens recall in November, the Live it Up Super Greens recall on January 15, and the...
Early Alert: Cook Medical Sizing Catheters
Cook Medical Sizing Catheters Removed Due to Risk of Device Breakage The U.S. Food and Drug Administration (FDA) has issued...
Medline Recalls Angiographic RA Control Syringes
Angiographic Syringe Recall: Medline Removes RA Control Syringes Due to Risk of Disconnection and Air Embolism The U.S....
EU Notified Bodies
Role, Responsibilities, and Strategic Considerations for Medical Device Manufacturers Notified Bodies (NBs) are independent...
FDA Approves First Generic for Equine Gastric Ulcers
FDA Approves First Generic Omeprazole Paste for Gastric Ulcers in Horses The U.S. Food and Drug Administration has approved...
FDA Class I Recall for Abiomed Impella Gen 1 Purge Cassettes
Medical Device Alert: Abiomed Impella Purge Cassette Recall (Class I) Abiomed has initiated a Class I recall, the most...
Class I Correction for Abiomed Impella Inaccurate Flow Readings
Abiomed Impella RP: FDA Class I Correction for Inaccurate Flow Readings Abiomed has issued an Urgent Medical Device...
Welcome to Medical Devices and Pharma, a website dedicated to providing timely and relevant medical device and pharma information to the regulated medical device and pharmaceutical industries, and consumers of those products.
Our goal is to provide organized, clearly written information from regulatory affairs and consumer perspectives.
- Key information from the Food and Drug Administration (FDA), the federal regulatory agency responsible for providing oversight over the industries and assuring the safety and efficacy of their products.
- Regulatory services for compliance, market access, and crisis management
- Information about innovation, including new products cleared for use in the U.S. market.
- News stories with topics ranging from product issues to market trends.
Perhaps most importantly, we will strive to maintain vigilance over product issues and their impacts. Check back here for consumer news, product alerts, and current litigation.
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