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Australia’s Therapeutic Goods Administration (TGA) has outlined its expectations for developers of in vitro diagnostic (IVD) self-tests for infectious diseases like influenza, hepatitis B and hepatitis C, chlamydia, gonorrhea and syphilis. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) resumed in-person inspections on March 29 but it is adopting a hybrid approach that allows for both remote and on-site elements. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said that paclitaxel drug-coated balloons or drug-eluting stents should not be used in the routine treatment of patients with widening of the arteries, as the mortality risk generally outweighs the benefits. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) issued a warning letter to Foshan Biours Biosciences, a combination drug/device manufacturing facility in Guangdong, China, following a records-based inspection that revealed inadequate testing and cleaning validation for the company’s biomedical patch. Read More
The FDA issued a warning letter to Tarmac Products, a Miami Gardens, Florida manufacturer of surgical wound dressings for issues with its medical device quality system. Read More
The EU’s Medical Device Coordination Group (MDCG) has clarified minimum performance requirements for devices intended to detect antibodies against the SARS-CoV-2 virus in a new guidance. Read More
The FDA is warning devicemakers that have been touting phony FDA registration certificates that give the false impression that their products have been cleared by the agency. Read More