Computer Generation of the FDA-1639 Form

Within the pharmaceutical industry, federal regulation mandates that all drug-related adverse effects reported to the manufacturer be, in turn, reported to the appropriate division of the government. The length of time allowed for reporting is also covered by regulation, and depends upon the nature and severity of the specific adverse reaction. For severe or unexpected reactions, the time requirement is just fifteen days. Therefore, it is in the best interest of the company to establish a procedure by which this reporting process can be expedited. Accordingly, the Stuart Pharmaceuticals Drug Experience Reporting System was developed.