October 2008 Federal Register: FDA Seeks Public Comments On A New MedWatch Portal; December 22 Deadline

(Posted by Tom Lamb at DrugInjuryWatch.com)

According to a Notice in the October 23, 2008 edition (Volume 73, Number 206) of the Federal Register, the FDA is proposing to change its MedWatch web site and the manner in which it collects information about suspected adverse events involving prescription drugs and other regulated products.

An October 23 article, "FDA to Ease Adverse Event Reporting", published online by HealthData Management (HDM) Breaking News, summarized this FDA Federal Register Notice as follows:

The Food and Drug Administration is seeking comment on a new Web portal under development that would provide a one-stop place to file reports of adverse events associated with the use of regulated products.

FDA has launched the development and implementation of the MedWatch/Plus/Portal, an enhanced, Web-based version of its existing MedWatch collection system. "The agency believes that one central point-of-entry will better enable persons to submit their information,"….

The portal will include a data collection tool called the "Rationale Questionnaire" to ease the reporting of a safety problem, according to the FDA. The questionnaire will ask simple questions to help users determine what information they should provide.

Anyone–including consumers, clinicians, researchers and medical device makers–will be able to report adverse events, medical errors, product complaints and other adverse reports. "The system will compile the user's responses into a standardized report that would be routed to the appropriate FDA organizational components for review and analysis,"….

To learn more, you can read the actual FDA Federal Register Notice, entitled "Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Data Collection Using MedWatch\Plus\ Portal and Rational Questionnaire" [Docket No. FDA-2008-N-0546]. 

This October 23 Federal Register Notice tells you how to submit a written or electronic commentto the FDA about its proposed MedWatch Portal, and informs us that the deadline for such comments is December 22, 2008.