FDA incident reporting system goes on-line

The US PDMA Alliance has announced the launch of an on-line incident reporting system, which allows its members and registered users of its web site to inform the Food and Drug Administration of loss, theft and other incidents involving prescription drugs.

The PDMA Alliance is an association of drugmakers and related firms which aims to improve compliance with the 1987 Prescription Drug Marketing Act. The Alliance said that the Act "requires companies to report significant loss, theft, falsification and diversion reports to the [FDA] within specified time frames."

The FDA Incident Reporting System allows the group's members to comply with the "5 & 30 day" reporting standards of the regulation, and is endorsed by the FDA.