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MedWatch^Plus Update

FDA is developing an electronic system for receiving, processing, storing, and analyzing adverse event reports and other safety information for all FDA-regulated products. This new system, MedWatch^Plus, will provide a single point of entry for reporters, enhance the current MedWatch program to include submission of reports for all FDA-regulated products, and combine the Agency's various safety reporting processes and systems. FDA and NIH are collaborating on the development of a Rational Questionnaire to make submitting adverse events and problem reports easier, more complete, and more consistent. FAERS (FDA Adverse Event Reporting System) will be FDA's new repository with enhanced analytic methods to enable staff to efficiently analyze thousands of safety reports and identify potential safety problems.

Note: Operations for submitting electronic reports through FDA's Electronic Submissions Gateway (ESG) will continue for those reporters who have established agreements with FDA (ESG link: http://www.fda.gov/esg/). FDA will continue to accept adverse event and safety reports using FDA's paper-based forms (i.e., 3500, 3500A, 1932, 1932a and VAERS-1) during the design, development, and implementation of the fully electronic MedWatch^Plus system.

Related Information

MedWatch^Plus / FAERS

Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Data Collection Using MedWatch\^Plus\ Portal and Rational Questionnaire (10/23/08)

Memorandum of Understanding between FDA and NIH

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