The FDA's Medical Dictionary for Drug Regulatory Affairs Alpha Test

The Food and Drug Administration (FDA), in conjunction with the International Conference on Harmonization (ICH), is pursuing a medical language thesaurus that could be used internationally for premarketing and postmarketing regulatory purposes regarding drugs, biologics, and devices. As part of a thorough, worldwide review of the Medical Dictionary for Drug Regulatory Affairs (MEDDRA) terminology by various interested parties, FDA, along with many representatives from various international organizations, has performed testing and evaluation of the current version of the United Kingdom's MEDDRA to identify items for further development and improvement. FDA's MEDDRA Alpha Test contains nine components and addresses both premarket and postmarket perspectives. This article documents and summarizes the MEDDRA Alpha Test and the opinions FDA received from both FDA reviewers and the medical informatics community concerning MEDDRA. Overall, the evaluation of MEDDRA conducted by FDA confirms that it is better than...