Medical Device and Pharmaceutical News
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Major Quality System Failures at Cardiac Device Manufacturer
Agency cites device classification disputes, inadequate manufacturing controls, and quality system deficiencies dating back to 2011An August 26, 2026, FDA warning letter to Peter Schiff Enterprises, a Tennessee manufacturer of cardiac devices, describes a troubling...
FDA Warning Letter for Stem Cell and Placenta Products
FDA challenges claims that biological products can treat serious diseases without demonstrating their safety and effectiveness through the agency's approval processStem cell therapies and products derived from human placental tissue have attracted considerable...
FDA Challenges Tides Medical’s Class I Device Classification
FDA's warning letter to Tides Medical illustrates how a device's intended use, not its manufacturer's chosen product code, determines its regulatory requirementsCan a medical device manufacturer classify an innovative wound-treatment technology as a Class I device...
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 Moves Toward New Peptide Compounding Policy
FDA Moves Toward New Peptide Compounding PolicyAgency submits proposed policy change for White House review as HHS signals support for expanded access to experimental peptides Nearly three months after an FDA advisory committee recommended adding six experimental...
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...
First T-Cell Therapy to Reduce Disease after Cell Transplant
FDA Approves First Regulatory T-Cell Therapy to Reduce Chronic Graft-versus-Host Disease After Stem Cell TransplantThe First Regulatory T (Treg) Cell-Based Immunotherapy The U.S. Food and Drug Administration (FDA) has approved Tregzi, the first regulatory T (Treg)...
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...
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...