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Manufacturers of home-use devices should conduct usability tests early in design development and at later stages as the product evolves to ensure that user interaction problems caused by human factors have been addressed, the FDA says in final guidance released Tuesday. Read More
Sites should state clearly what patients can expect regarding access to personal results from clinical trials in their informed consent documents, an expert witness told the Secretary’s Advisory Committee on Human Research Protections in Rockville, Md., on July 22. Read More
Must investigators obtain informed consent anew in order to use aggregated clinical trial data for secondary purposes? What purpose does this data serve to improve standards of care? And are there risks inherent in using such data? Read More
Evaluations of diagnostic test accuracy studies should include separate meta-analysis of positive and negative likelihood ratios, according to a draft guideline by the EU Network for Health Technology Assessment. Read More
Sponsors designing clinical trials that involve certain vulnerable patient populations will soon face greater scrutiny from institutional review boards, under newly issued FDA guidance. Read More
The Office of Science and Technology Policy’s Critical and Strategic Minerals Supply Chain Subcommittee is requesting information on the “current and future production of and demand for relevant materials, concerns related to raw material availability, and overall market dynamics” in key industry sectors. Read More