The Food and Drug Administration (FDA) regulations state very clearly the definition, time frames and overall requirements for reporting IND safety events; the requirements can be found on the FDA website, the regulation is, 21.312.32. The recording of adverse events usually begins with the signing of the Informed Consent Form and ends at some period after participation in the clinical trial. Analysis and classification of an adverse event is critical because the safety of the subject is paramount and any mis-classification can lead to incorrect labeling. Balancing risk with benefit is difficult at best and the assessor certainly has to consider quality of life of the subject when making such an assessment. Also, confirmation and nature of exposure, as well as unexpectedness are important and can be easily accessed by the availability of supportive information and expected occurrence rate.
Even with the Medwatch reporting system the FDA appears to have better management of safety events through the Adverse Event Reporting System (AERS) which supports the FDA’s post-marketing safety surveillance program for all approved drug and therapeutic biologic products. AERS contains adverse drug reaction reports that FDA has received from manufacturers.
Safety assessments and tolerability more time than not kills further development of a pre-marketed product and if negative can lead to painful consequences for the patient and manufacturer of a marketed product.