Regulatory requirements adverse events

Decisions have to be made by pharmaceutical companies and regulatory authorities about whether a drug can cause a particular adverse event (AE) so that an appropriate action can be taken. What does can cause mean Does it imply certainty In many cases to wait for certainty before taking action would entail many patients suffering unnecessarily. The degree of certainty or probability required will vary according to the situation. 

The aims of causality assessment are manifold. Adverse events need to be classified, a decision needs to be made whether a drug has caused this event, regulatory requirements need to be satisfied, signal recognition can be aided, and finally, at the end of this process, a label change may be necessary. 

Adverse event documentation and reporting The investigator and staff must understand the regulatory requirement for reporting adverse drug... 

Most regulatory authorities allow some relaxation of the requirement for studies when the drug is for single-dose only, and when adverse events are Cmax rather than AUC-related (because Cmax usually varies little with reduce rate of clearance under these conditions). 

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