Informed Consent
1 Office of Epidemiology and Biostatistics FDA, Rockville, MD
In Reply.
Dr Cook's letter raises serious concerns about the medical-legal implications of the use of the term "adverse reaction reports" to describe reports of temporally associated events suspected of being caused by a drug or vaccine exposure. We have chosen to use this term because, in most cases, the reporter has not merely seen an event following an exposure but has some level of suspicion that it might be linked to the exposure.




