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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is seeking public feedback on a plan that would end regulatory reciprocity between the UK and the EU for drug and device review and approvals. Read More
The Patient Engagement Advisory Committee (PEAC) — FDA’s only advisory committee comprised solely of patients, caregivers, and patient advocates — is seeking guidance on improving access to home-use medical devices in a diverse patient population, from device design to clinical trials and marketing in an all-day meeting on Sept. 6. Read More
The FDA has deemed as class I another in a series of voluntary recalls from Getinge/Maquet/Datascope for various models of its Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pump (IABP), this time for the potential of the device to overheat and shut down. Read More
The FDA has deemed Hamilton Medical’s recall of certain of its ventilators as class I, the most serious type of recall as use the device may lead to serious injury or death. Read More
After inquiries about food, the FDA Office of the Ombudsman hears most often from device companies — because there are more small companies in that area of the industry — and they need help to solve a problem they’re having with the agency, said office director Laurie Lenkel during an Alliance for a Stronger FDA webinar Wednesday. Read More
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
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