FDA’s deadline problem?

Wall Street Journal

3 January 2020 - Rush to meet end-of-year drug-approval deadlines leads to more adverse effects, new study shows.

More drugs are approved in December than any other time of year—but the burst of activity has an unintended side effect: The end-of-year approvals are later associated with more hospitalisations, life-threatening events and deaths, according to a new study.

“We see about twice as many adverse effects,” said Lauren Cohen, a professor of finance and entrepreneurial management at Harvard Business School who, with colleagues at MIT and the University of Texas at Dallas, documented the pattern.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation , Timelines , Safety