11.01.07
At the persistent urging of industry and its trade organizations, FDA finally released a guidance document for dietary supplement adverse event reporting (AER) on October 15th. The publication of this guidance fulfills a portion of FDA’s requirement under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which goes into effect on December 22, 2007. The draft guidance describes the minimum data elements required for serious adverse event reports for dietary supplements. It also provides guidance on how, when and where to submit a serious adverse event report for a dietary supplement, as well as on records maintenance and access for serious and non-serious adverse event reports and related documents. The agency also disclosed that it is preparing a separate guidance on the reporting of serious adverse events associated with nonprescription human drug products that were also affected by the legislation passed by the U.S. Congress last year. As is standard for the issuance of such guidance, there will be a 60-day period during which comments may be submitted. (For more information on the new law, see this month’s “Capitol Comments” column, which starts on page 24.)