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Sponsors of new medical technologies must include a description of any pediatric subpopulations that suffer from the condition the product is intended to treat. Read More
Northwestern University has provided information to a Senate panel investigating a clinical trial conducted there several years ago, but the senator behind the inquiry says the school is far from in the clear. Read More
Manufacturers can expect more guidance on how to conduct patient preference research during device development, thanks to a $500,000 FDA grant to the Medical Device Innovation Consortium. Read More
Devicemakers will be able to submit traditional 510(k)s electronically to two CDRH device branches, under an experimental program announced Thursday. Read More
The FDA’s Denver office will host a two-day public workshop on global drug and device safety during an educational conference sponsored by the Association of Food and Drug Officials. Read More