Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationFDA and global regulatory affairs, consumer health, and professional development
Expert guidance for industry professionals and clear, reliable information for patients and consumers
FDA Early Alert – Hamilton Medical Breathing Circuit Sets
FDA Issues Early Alert for Hamilton Medical Breathing Circuit Sets Following Reports of Serious Injuries The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding certain Hamilton Medical coaxial breathing circuit sets used with HAMILTON-C1,...
FDA Early Alert for GE HealthCare Infant Resuscitation Systems
FDA Issues Early Alert for GE HealthCare Infant Resuscitation Systems Due to Oxygen Blender Issue Early Alert for GE HealthCare Infant Resuscitation Systems The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding a potentially high-risk issue...
Major Eye Drop Recall Shows Manufacturing and Inspection Issues
Kian Pee Wan Capsules Recalled for Undeclared Drug Ingredients
Kian Pee Wan Capsules Recalled Due to Undeclared Drug Ingredients Aphreseller (Buy-herbal.com), an online seller based in Flushing, New York, has voluntarily recalled all lots of Kian Pee Wan capsules after testing identified the presence of undeclared drug...
FDA Early Alert – Hamilton Medical Breathing Circuit Sets
FDA Issues Early Alert for Hamilton Medical Breathing Circuit Sets Following Reports of Serious Injuries The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding certain Hamilton Medical coaxial breathing circuit sets used with HAMILTON-C1,...
FDA Early Alert for GE HealthCare Infant Resuscitation Systems
FDA Issues Early Alert for GE HealthCare Infant Resuscitation Systems Due to Oxygen Blender Issue Early Alert for GE HealthCare Infant Resuscitation Systems The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding a potentially high-risk issue...
FDA-Approved Vivistim: A New Pathway in Stroke Recovery
Vivistim implantable vagus nerve stimulator. Source: Vivistim.com.FDA-Approved Vagus Nerve Stimulation Device Opens a New Pathway in Stroke Recovery A company behind one of the world’s most closely watched neurorehabilitation technologies is preparing for a major new...
FDA Warning Letter Cites Systemic Aseptic Manufacturing Failures
Medline Warning Letter Signals Systemic Quality Failures in Cardiovascular Device Manufacturing The FDA has issued a Warning Letter to Medline Industries (NAMIC Division) following a December 2025 inspection, identifying significant Quality System Regulation (QSR)...
FDA Warns Leading Edge Health Over Unapproved New Drugs
FDA Warning Letter Targets Erectin Stimulating Gel and VigRX Delay Wipes FDA issued a warning letter to Leading Edge Health Inc. after reviewing the company’s website and determining that two sexual health products were being marketed as unapproved new drugs. The...
FDA Targets Online Marketing of Unapproved Drugs
FDA Issues 14 Warning Letters Targeting Online Unapproved Drug Sales The U.S. Food and Drug Administration (FDA) has issued a coordinated series of warning letters targeting companies marketing unapproved drug products online, signaling an intensified enforcement...
FDA Approves First Treatment to Reduce Risk of Acute Pancreatitis
FDA Approves First Treatment Proven to Reduce Acute Pancreatitis Risk in Severe HypertriglyceridemiaAn important example of the distinction between surrogate endpoints and clinical outcomes in drug development The U.S. Food and Drug Administration (FDA) has approved...
Gas Station Drugs: The Regulatory Wild West
Walk into enough gas stations, smoke shops or convenience stores in America and eventually you will encounter a strange modern pharmacy hiding in plain sight. Brightly colored “energy shots.” “Herbal” sexual enhancement pills. Kratom capsules and concentrated...
FDA Grants Full Approval for Canine Epilepsy Drug
Approval Granted After Expanded Conditional Pathway The U.S. Food and Drug Administration has granted full approval to KBroVet® (potassium bromide chewable tablets) for the control of seizures in dogs diagnosed with idiopathic epilepsy, a chronic seizure disorder with...
FDA Advisory for Contaminated Raaw Energy Dog Food
The U.S. Food and Drug Administration (FDA) has issued a public advisory warning pet owners not to feed eight identified lots of Raaw Energy dog food after testing confirmed contamination with multiple pathogenic bacteria, including Listeria monocytogenes, Salmonella,...
FDA Approves First Generic Fenbendazole Oral Suspension
Defendazole™ (fenbendazole) 10% Oral Suspension The U.S. Food and Drug Administration has approved Defendazole™ (fenbendazole) 10% oral suspension, the first FDA-approved generic fenbendazole dewormer for use in beef and dairy cattle and goats. Defendazole is...
FDA Approves First Generic for Bovine Respiratory Disease
nixiFLOR, the first generic version of Resflor GOLD The U.S. Food and Drug Administration has approved nixiFLOR, an injectable solution combining florfenicol and flunixin meglumine, for the treatment of bovine respiratory disease (BRD) and the control of...
Live it Up Super Greens Recalled Over Salmonella Contamination
Live it Up Super Greens Recalled Over Possible Salmonella Contamination Editor’s Note: The original recall notice was issued on January 15, 2026 and is summarized here for reference purposes. Superfoods, Inc., doing business as Live it Up (New York, NY), has issued a...
Do Not Blame FDA for Lax Oversight of Dietary Supplements
A Regulatory System Designed to Fail The recent recalls involving contaminated moringa leaf powder should alarm every company that manufactures, imports, or sells dietary supplements in the United States. They highlight a reality that consumers rarely understand, and...
Has Industry Self-Regulation Been Effective?
Has Industry Self-Regulation Been Effective? Supplement industry self-regulation has helped in limited ways, but it has not been sufficient to ensure reliable safety. What has worked Voluntary GMP certifications (e.g., NSF, USP, Informed Choice) A minority of...
Why DSHEA Reform Must Be a Priority
Why DSHEA Reform Must Be a Priority The recent wave of moringa-related contamination recalls – touching national retail chains and rippling through dozens of contract manufacturers – has forced an uncomfortable question into public view: How was a single tainted...
FDA Clears First OTC Continuous Glucose Monitor for Children
Regulatory Snapshot Device: Stelo® Glucose Biosensor System (Dexcom, Inc.)Indication: Continuous glucose monitoring for individuals ages 2 years and older who do not use insulin, including children with diabetes managed through oral medications and individuals seeking...
Gas Station Drugs: The Regulatory Wild West
Walk into enough gas stations, smoke shops or convenience stores in America and eventually you will encounter a strange modern pharmacy hiding in plain sight. Brightly colored “energy shots.” “Herbal” sexual enhancement pills. Kratom capsules and concentrated...
Major Eye Drop Recall Shows Manufacturing and Inspection Issues
Kian Pee Wan Capsules Recalled for Undeclared Drug Ingredients
Kian Pee Wan Capsules Recalled Due to Undeclared Drug Ingredients Aphreseller (Buy-herbal.com), an online seller based in Flushing, New York, has voluntarily recalled all lots of Kian Pee Wan capsules after testing identified the presence of undeclared drug...
FDA Approves First Oral PCSK9 Inhibitor for High Cholesterol
FDA Approves Lipfendra, the First Oral PCSK9 Inhibitor for High CholesterolLipfendra offers patients a once-daily pill...
FDA Approves Retevmo for RET Fusion-Positive Solid Tumors
FDA Grants Full Approval to Retevmo for RET Fusion-Positive Metastatic Solid TumorsApproval expands precision medicine...
FDA Approves Trutakna for Rare Kidney Disease IgA Nephropathy
FDA Approves Trutakna for IgA Nephropathy, First Dual BAFF/APRIL Therapy to Reduce ProteinuriaFirst therapy to target two...
FDA Warning Letters Target Online Ketamine Sellers
Seven Warning Letters Signal Increased FDA Scrutiny The U.S. Food and Drug Administration (FDA) has launched a coordinated...
FDA Warns Wild Arabic Herbs Over Product Cancer Claims
FDA Warns Wild Arabic Herbs Over Cancer Claims for Herbal Product FDA issued a warning letter to Wild Arabic Herbs after...
FDA Warns Amazon for Unapproved Drugs Sold On Its Website
FDA Issues Warning Letter to Amazon for Unapproved Drug Products FDA issued a warning letter to Amazon.com, Inc. after...
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.
Medical Devices
Pharma