How are safety signals detected, evaluated, and managed?

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Data spontaneously reported to sponsor company may be incomplete or confounded10,14
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It can be challenging to determine causality if limited information is reported10
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Signal evaluation can include assessment of pre-clinical, clinical, post-marketing, and epidemiology data10,17

Sponsor companies communicate individual AEs and signals to regulatory agencies via individual case study reports and periodic aggregate safety reports according to timelines specified by regulatory guidelines1,9,10,12

Regulatory authorities have the final decision on the content and language included in the product label and what subsequent action may be required if signals are identified post-approval8,9,17,19,20