Reports Received and Reports Entered into AERS by Year

(As of June 30, 2009)

These data describe total numbers of reports received for drugs and therapeutic biologic products and the number of reports we entered into the AERS database. Not all of the reports that FDA receives for drug and therapeutic biologic products are entered into the AERS database. At the present time, we are entering reports of the following types:

• • Reports submitted directly to FDA (not submitted through manufacturers)
  • Reports submitted on 3500A (or CIOMS) forms by manufacturers that are categorized as:
    • 15-day reports
    • serious Periodic reports, or
    • nonserious Periodic reports for new molecular entity (NME) products within the first 3 years following FDA approval
  • Reports submitted electronically by manufacturers regardless of category.

A manufacturer's 15-day report is a report that contains at least one event that is not currently described in the product labeling and the patient outcome is serious. A manufacturer's Periodic report is a report that did not meet the criteria for a 15-day report.  Manufacturers submit Periodic reports to FDA quarterly for newer drugs (FDA-approved for three years or less) and annually for older drugs.

Figure 1. This figure illustrates the number of reports received (solid bars) and entered (checkered bars) into AERS by type of report since the year 2000 until the end of the second quarter of 2009.

This table represents the number of reports received by FDA and entered into AERS by type of report since the year 2000 until the end the second quarter of 2009.