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U.S. Department of Health and Human Services

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Percentage of serious adverse event reports reviewed within 90 days of submission(1)

Dictionary: Adverse events are defined in 21 CFR Part 312.32 as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. As described in Part 312, sponsors of investigational new drug applications (INDs) are required to submit to FDA IND safety reports for 1) any suspected adverse reaction that is both serious and unexpected no later than 15 calendar days after the sponsor determines that the information qualifies for reporting and 2) any unexpected fatal or life-threatenning suspected adverse reaction no later than 7 calendar days after the sponsor's initial receipt of the information. Sponsors are not required to submit IND safety reports for other types of adverse events, but may do so voluntarily. This measure will allow OTAT to monitor its performance in reviewing serious adverse event reports (those required to be submitted to FDA within 15 or 7 days) within timeframe goals. Consistent and timely review of serious adverse event reports will allow OTAT, FDA to assess potential safety risks associated with products and at-risk patient populations. Assessment of these adverse event data will provide for better patient safety, and facilitate efficient clinical development of novel cell and gene therapy products.

Information is current as of September 30, 2021.

Fiscal Year - 2021

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TimeTargetPercent
Oct - Dec 2020N/A96
Jan - Mar 2021N/A95
Apr - Jun 2021N/A88
Jul - Sept 2021N/A83

FY 2021 Total: 91%

Number of serious adverse event reports reviewed within 90 days of submission

Fiscal Year - 2021
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TimeTargetNumber
Oct - Dec 2020N/A149
Jan - Mar 2021N/A164
Apr - Jun 2021N/A161
Jul - Sept 2021N/A114

FY 2021 Total: 588

Number of serious adverse event reports received by OTAT within the quarter

Fiscal Year - 2021
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TimeTargetNumber
Oct - Dec 2020N/A156
Jan - Mar 2021N/A173
Apr - Jun 2021N/A184
Jul - Sept 2021N/A138

FY 2021 Total: 651

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.

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