Medical Device and Pharmaceutical News
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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...
FDA Streamlines Biosimilar Development to Reduce Drug Costs
FDA Moves to Streamline Biosimilar Development and Reduce Drug Costs The U.S. Food and Drug Administration (FDA) has announced new steps to simplify the development pathway for biosimilar medicines, a move intended to reduce development costs and improve patient...
FDA Inspections for Domestic and Foreign Device Manufacturers
Early Observations: Comparing FDA Inspection OutcomesStriking Difference in Inspection Outcomes for Domestic and Foreign Device Manufacturers One of the most revealing early insights from our analysis of FDA inspection data emerges when the results are separated...
A Leap in FDA Transparency – The Electronic FOIA Reading Room
Exploring FDA’s FOIA Electronic Reading RoomA New Window into Inspection Findings The U.S. Food and Drug Administration (FDA) has expanded public access to regulatory information through its FOIA Electronic Reading Room, making large datasets from inspections and...