FDA and global regulatory affairs, consumer health, and professional development
Expert guidance for industry professionals and clear, reliable information for patients and consumers
FDA Requires New GLP-1 Drug Warning for Vision Loss Risk
Agency cites potential increased risk of rare optic nerve condition following review of clinical trials and postmarket safety dataThe U.S. Food and Drug Administration (FDA) is requiring manufacturers of all glucagon-like peptide-1 receptor agonist (GLP-1 RA)...
Pharmacal Recalls MG217 Eczema Cream
Pharmacal Recalls MG217 Eczema Cream Due to Staphylococcus aureus ContaminationFDA posts nationwide recall after microbial contamination found in topical skin treatment Pharmacal has voluntarily recalled one lot of MG217 Multi-Symptom Treatment Cream & Skin...
Cefazolin Injection Recalled Due to Cardboard in Sterile IV Solution
Baxter Recalls Cefazolin Injection Sterile IV SolutionCardboard Particulate Matter Found in a Sterile Intravenous Infusion Bag Baxter International has voluntarily recalled one lot of Cefazolin in Dextrose Injection, USP, 2 g/100 mL after a report of cardboard...
FDA Closes Moringa Salmonella Outbreak Investigation
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have concluded their investigation into a multistate Salmonella Typhimurium outbreak linked to MOGO-brand moringa powder capsules distributed by MOGO Moringa LLC of St. Louis,...
Class 1 Recall for HemosIL AcuStar HIT Antibody Test
HemosIL AcuStar HIT-IgG(PF4-H). Source: fda.govPerformance problems could produce false-negative results, potentially delaying diagnosis of a dangerous reaction to heparin.The U.S. Food and Drug Administration (FDA) has identified a recall of certain lots of the...
Closing the Arterial Opening Without Surgery
Vivasure Medical's PerQseal Elite offers a minimally invasive approach to closing large arterial openings following cardiovascular procedures.Vivasure Medical's PerQseal Elite offers a minimally invasive approach to closing large arterial openings following...
FDA Approves Amplatzer Paraclose for Heart Valve Leaks
Abbott's Amplatzer Paraclose PVL Occluder offers a minimally invasive alternative for patients who develop a significant complication following heart valve replacement surgery.Heart valve replacement surgery can be lifesaving for patients with damaged or diseased...
October 2026 Premarket Approval (PMA) Authorizations
Three original device approvals and 218 supplements / noticesFDA's October activity highlights three newly approved medical devices and the extensive regulatory oversight required to maintain and modify products already on the market.The U.S. Food and Drug...
FDA Requires New GLP-1 Drug Warning for Vision Loss Risk
Agency cites potential increased risk of rare optic nerve condition following review of clinical trials and postmarket safety dataThe U.S. Food and Drug Administration (FDA) is requiring manufacturers of all glucagon-like peptide-1 receptor agonist (GLP-1 RA)...
When Political Priorities and FDA Science Collide
HHS proposes expanding access to six unapproved peptides despite objections from FDA scientists. This raises questions about regulatory oversight, patient safety, and the distinction between enforcement discretion and drug approval.The Trump administration is moving...
What to Know about FDA’s Revised Peptide Guidance
What Manufacturers Need to Know Seventeen revised draft product-specific guidance documents reflect FDA's evolving scientific and regulatory approach to generic peptide drug development. On July 28, 2026, the U.S. Food and Drug Administration (FDA) published 17...
The Regulatory Dilemma of Experimental Peptides
As demand for experimental peptides grows, a fundamental question confronts federal regulators. Can access to unapproved drug products expand without compromising the standards intended to protect patients? The growing popularity of experimental peptides such as...
FDA Warning Letter to AHC Products, Inc. for CGMP Violations
FDA Warning Letter to AHC Products, Inc. for CGMP Violations The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to AHC Products, Inc. of Winchester, Kentucky, citing significant violations of Current Good Manufacturing Practice (CGMP) regulations...
FDA Warning Letter Cites Illegal Drug Residue Levels in Dairy Cow
Letter Highlights FDA's Role in Protecting the Food Supply from Excessive Drug Residues When most people think about food safety inspections at slaughterhouses, they think of the U.S. Department of Agriculture. Few realize that the U.S. Food and Drug Administration...
FDA Warning Letter Targets Unapproved Fish and Bird Antibiotics
Letter Cites Unapproved Animal Drugs, Misbranding, and Antimicrobial Stewardship Concerns The U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) has issued a Warning Letter to The Fish Aid, an online distributor of antibiotics marketed for...
FDA Approves First Veterinary Amlodipine for Feline Hypertension
The U.S. Food and Drug Administration has approved Amodip (amlodipine besylate) chewable tablets for the control of systemic hypertension in cats. This approval marks a regulatory milestone as the first FDA-approved amlodipine product for veterinary use and the second...
Editorial: Two Days Later, Another Moringa Recall
Recurring Moringa Recalls Highlight Ongoing Supply Chain Concerns On July 17, the U.S. Food and Drug Administration officially closed its investigation into a multistate Salmonella outbreak linked to MOGO-brand moringa capsules. The outbreak was not insignificant....
Moringa Capsules Recalled for Potential Salmonella Contamination
Zen Principle Recalls Moringa Capsules After FDA Detects Salmonella in Raw Ingredient Relay Peak Research LLC, doing business as Zen Principle Naturals, has voluntarily recalled one lot of its Zen Principle® Moringa Capsules after learning that the raw moringa leaf...
FDA Closes Moringa Salmonella Outbreak Investigation
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have concluded their investigation into a multistate Salmonella Typhimurium outbreak linked to MOGO-brand moringa powder capsules distributed by MOGO Moringa LLC of St. Louis,...
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...
Pharmacal Recalls MG217 Eczema Cream
Pharmacal Recalls MG217 Eczema Cream Due to Staphylococcus aureus ContaminationFDA posts nationwide recall after microbial contamination found in topical skin treatment Pharmacal has voluntarily recalled one lot of MG217 Multi-Symptom Treatment Cream & Skin...
Product Safety Agency Demands Patients’ ER Hospital Records
Trump Administration Demands Hospitals Share Emergency Room Records
Eight Months of Moringa Salmonella Outbreaks
Recurring Salmonella Outbreaks Raise Questions About Supplement Oversight Since November 2025, the U.S. Food and Drug Administration has investigated and coordinated multiple recalls involving moringa dietary supplements contaminated with Salmonella. What initially...
FDA Closes Moringa Salmonella Outbreak Investigation
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have concluded their investigation into a multistate Salmonella Typhimurium outbreak linked to MOGO-brand moringa powder capsules distributed by MOGO Moringa LLC of St. Louis,...
FDA Requires New GLP-1 Drug Warning for Vision Loss Risk
Agency cites potential increased risk of rare optic nerve condition following review of clinical trials and postmarket...
Class 1 Recall for HemosIL AcuStar HIT Antibody Test
HemosIL AcuStar HIT-IgG(PF4-H). Source: fda.govPerformance problems could produce false-negative results, potentially...
Closing the Arterial Opening Without Surgery
Vivasure Medical's PerQseal Elite offers a minimally invasive approach to closing large arterial openings following...
FDA Approves Amplatzer Paraclose for Heart Valve Leaks
Abbott's Amplatzer Paraclose PVL Occluder offers a minimally invasive alternative for patients who develop a significant...
FDA Approves Treatment for Advanced Head and Neck Cancer
Rybrevant Faspro receives accelerated approval following promising clinical trial results in patients with limited...
FDA Approves Treatment that Targets SMA Muscle Loss
Isembyld introduces a new treatment approach for patients with SMA by addressing muscle weakness alongside existing...
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