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In new guidance, FDA outlines seven sources of confirmatory evidence to support single clinical studies
The FDA has just released a long-anticipated draft guidance giving sponsors practical information on when and how to leverage confirmatory evidence to support a drug that is seeking approval using a single adequate, well-controlled clinical study to demonstrate effectiveness in lieu of additional clinical evidence. The agency walks through the conditions that must be met for appropriate use, giving use cases and examples of suitable data.
Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance
A long-awaited draft guidance on Prescription Drug Use-Related Software (PDURS) outlines when information from digital health tools could be represented on prescription drug labeling. Per the new draft guidance, key considerations include where the software gets its data inputs and what the expected benefit of the tool’s use could be.
Earthjustice sues EPA over polyether polyols standards
Earthjustice has sued the Environmental Protection Agency, seeking to require the agency to review air emissions standards for polyether polyols production under section 112(d)(6) of the Clean Air Act and determine whether action to revise those standards is required.
France finds unclear disinfectant labeling to blame for chemical burns in children
The French environment and safety agency (ANSES) has identified a pattern of chemical incidents, reporting more than one hundred cases of schoolchildren sustaining chemical burns in recent years. It appears the issue is largely the result of unclear labeling for biocidal disinfectants, an aspect French regulators may flag in future market authorization evaluations for these products.
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