date:Nov 19, 2012
nberg, Traurig LLC. They certainly could have been, but responsibility is not the threshold. Youre required to make the report to the agency whether [the product] is actually tied to the extreme adverse reaction or not.
The FDA uses the reports as a basis for follow-up investigation, according to Tamara Ward, a public affairs officer with the FDA.
The FDA considers an adverse event report as a sign of a possible problem and is therefore seeking any additional available data such as: to solicit