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A pan-European health technology assessment body has recommended that EU cost-effectiveness evaluators compare new pharmaceuticals against the most relevant standards of care, in a new framework to harmonize different member states’ individual guidelines on making coverage decisions. Read More
A sweeping rewrite of Canada’s drug safety law that authorizes the government to order recalls and require labeling changes and postmarket studies could spell new worries for devicemakers because it also allows for the release of confidential business information on unsafe products. Read More
International medical device regulators are trying to entice more companies to participate in a single-audit pilot program, promising they will receive no warning letters unless there is an immediate threat to public health. Read More
The FDA has requested a meeting with Express Diagnostics International, as well as an independent audit of the company’s manufacturing practices, following an inspection that uncovered problems with testing and labeling of the company’s products. Read More
Labeling and packaging errors and software problems accounted for more than 40 percent of medical device recalls during the 2014 third quarter, according to compliance company Stericycle. Read More
The FDA is revising an August final guidance on design considerations for home use devices to reflect growing concerns about power outages and the potential for electromagnetic disturbances. Read More
The FDA slapped Sollentuna, Sweden-based MKL Diagnostics with a warning letter for failing to have a design control procedure for its Phadebact test kits. Read More
By the end of next year, the FDA expects to release rules on the regulation of sunlamps, postmarket safety reporting requirements for combination products and international clinical trials, among other priorities. Read More
The British government says it will conduct a massive review of how new medical devices and in vitro diagnostics are developed, with the aim of bringing products to market faster and speeding patient access. Read More