FDA offices agree on regulatory authorities for safety

07/2/2008 | TheRPMReport.com

The FDA's drug-review and drug-safety offices have signed a memorandum of agreement to divide regulatory authorities on drug-safety issues. The deal gives the Office of Surveillance and Epidemiology a greater voice and lead authority on observational epidemiological studies and medication-error prevention, including the process of reviewing proprietary names. Center for Drug Evaluation and Research Director Janet Woodcock said the agreement "supports the work of multidisciplinary teams," allows team members to express their opinions and provides an opportunity to resolve differences.

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