Tag Archives: medical device

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FDA Proposes New Guidelines for Accepting Data Conducted Overseas

New acceptance guidelines proposed by the FDA regarding clinical data on medical devices gathered overseas have created a stir in the industry. The FDA noted that “increasing globalization of clinical trials presents challenges to both U.S. and foreign regulators,” and among those challenges are resource constraints posed by the increase in the number...

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Calls For Transparency Amid Investigation Into FDA Advisory Committee Members’ Financial Ties to Medical Device Companies

An investigation into the financial connections between medical device companies and FDA advisory committees, which make recommendations on the approval and regulation of these pharmaceutical products, has called into question the ability of these doctors to make unbiased decisions in advising the country’s top public health and safety agency. Information uncovered by The Wall...
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