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Our coverage spans a bone graft product that caused a tuberculosis infection, a subcutaneous cancer treatment, a warning letter for an eye drop manufacturer, 300 higher risk patients with a recalled Medtronic cardiac pump, and a lawsuit by Insulet against a competitor for intellectual property theft. Read More
Upcoming events in the coming weeks include ten FDA advisory committee meetings as well as the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual Inspections vSummit and webinars from FDAnews, a WCG company, on calculating sample sizes for verification and validation activities and medical device counterfeiting. Read More
The FTC and the Department of Justice (DOJ) will co-host a Sept. 5 workshop on draft merger guidelines the agencies propose to use when assessing whether a merger may violate antitrust law and stifle competition. Read More
The Environmental Protection Agency (EPA) must complete its work on the final rule governing commercial sterilization using ethylene oxide (EtO) by March 1, 2024, following the government’s signature on a consent decree that settles a complaint against the EPA filed by multiple groups in December 2022. Read More
Despite customers’ reporting symptoms that included stroke, memory loss, atrial fibrillation, bradycardia and seizures after using Fisher Wallace Labs’ at-home cranial electrotherapy stimulator (CES) device, the company did not submit the required Medical Device Reporting within 30 days to let the FDA know that serious adverse events (SAE) had occurred. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More
Withings’ Body Scan health station received FDA clearance for its weight-scale style device that provides users a home electrocardiogram (ECG). Read More
Over the past week, the FDA issued a draft guidance on product-specific guidances, extended the comment period on a draft guidance for human cellular and gene therapy products, published a list of bulk drugs for which there is a clinical need under section 503B of the FD&C Act and notices of advisory committee meetings for oncologic drugs, endocrinologic and metabolic drugs and vaccines and related biological products. Read More
The FDA has announced a new testing tool, and approved several systems for cryoablation, donor lung preservation and cervical disc replacement. Read More