Medical Device and Pharmaceutical News
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Class I Correction for Homecare Bed Fire and Entrapment Risks
Medline Homecare Beds: FDA Class I Correction for Fire and Entrapment Risks Medline Industries has issued a critical safety correction involving multiple models of homecare beds following reports of overheating components, electrical hazards, and patient entrapment...
Nivolumab Combination Therapy for Advanced Hodgkin Lymphoma
FDA Approves Nivolumab Combination Therapy for Advanced Hodgkin Lymphoma On March 20, 2026, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo, Bristol Myers Squibb) in combination with chemotherapy (AVD regimen) for adult and pediatric patients...
When a Small Process Failure Becomes a Patient Safety Event
What the Erbe Cryoprobe Alert Teaches Us About Modern Device Quality The FDA’s recent Early Alert regarding flexible cryoprobes manufactured by Erbe USA is a textbook example of a fundamental truth in medical device quality. That small manufacturing deviations can...
FDA Flags High-Risk Issue with Erbe Flexible Cryoprobes
FDA Flags High-Risk Issue with Erbe Flexible Cryoprobes The FDA’s Center for Devices and Radiological Health (CDRH) has issued an Early Alert regarding a potentially high-risk issue involving certain flexible cryoprobes manufactured by Erbe USA. Issue Overview Erbe...
EPA Proposes Rollback of EtO Sterilization Emissions Limits
EPA Proposes Rollback of Ethylene Oxide Sterilization Emissions LimitsThe U.S. Environmental Protection Agency has proposed weakening restrictions on emissions of ethylene oxide (EtO) from commercial sterilization facilities that sterilize medical devices. EtO plays a...
Adulterated Supplements and the Limits of Post-Market Oversight
FDA Recall of Adulterated Supplements Raises Questions About DSHEA Oversight Lessons from the “Boner Bear” Recall The FDA’s recent recall of several honey-based “sexual enhancement” supplements illustrates a recurring problem in the dietary supplement marketplace:...
FDA Recalls “Sexual Enhancement” Supplements
FDA Recall Highlights Ongoing Risks of Adulterated “Sexual Enhancement” Supplements Pure Vitamins and Natural Supplements, LLC (Tampa, FL) has issued a voluntary nationwide recall of several honey-based dietary supplement products after FDA laboratory testing detected...
FDA’s AEMS: Real-Time Drug and Device Safety Monitoring
FDA’s AEMS: The Beginning of Real-Time Drug and Device Safety MonitoringThe U.S. Food and Drug Administration has launched a new platform that could fundamentally reshape how post-market safety signals are detected and analyzed. Announced on March 11, 2026, the FDA...
When Randomized Trials Are Not Possible
When Randomized Trials Are Not Possible: How Real-World Evidence Is Shaping FDA Drug Approvals The U.S. Food and Drug Administration’s recent approval of leucovorin (Wellcovorin) for cerebral folate transport deficiency caused by FOLR1 gene variants highlights an...
FDA Approves Cerebral Folate Transport Deficiency Treatment
FDA Approves First Treatment for Cerebral Folate Transport Deficiency The U.S. Food and Drug Administration (FDA) has approved an expanded use of Wellcovorin (leucovorin calcium) tablets to treat patients with cerebral folate deficiency caused by variants in the...