Causes, Not Just Cases® | The Motley Rice Law Blog

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August 19, 2019

FDA’s push for transparency long overdue

Generally speaking, manufacturers are required to submit individual reports to the FDA for each patient who sustains an injury or complication caused by a medical product. Established in 1997, Alternative Summary Reporting Program allowed manufacturers to bypass that standard by submitting quarterly summaries for cases that involve “well-known” complications. The FDA claims that this policy allowed the agency to “more efficiently review reports of well-known, well-understood adverse events.” However, the public was largely kept in the dark because this massive database was kept hidden, available only to the FDA – until now.

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