Compiled by Karen Moltenbrey
Mercury measurement method
Micro Analytical Systems, Inc. (San Rafael, CA; www.safeharborfoods.com) has developed a process that, for the first time, allows large-scale mercury testing of seafood, and is installing test equipment in participating fish processing plants. Once a core sample is taken from a fish, it’s inserted into the testing unit, which quickly analyzes it for mercury content. The company plans to use the new technology to introduce a line of lower mercury-certified seafood in supermarkets under the Safe Harbor™ label. The Safe Harbor certification assures consumers that the mercury content is among the lowest available for that species. The company plans to introduce the lower mercury-certified seafood in supermarkets in early 2006.
Earlier meetings with FDA can streamline drug review
The FDA has released a new report that examines the way the agency reviews applications for drugs and biologics that have not previously been approved by the FDA. The report was commissioned to examine differences in applications approved by the agency during the first round of review (first cycle) compared to those applications that took multiple reviews (multi-cycle) before approval. “Earlier consultation and feedback from FDA on the sponsor’s development program is critical to ensuring safe and effective study designs, and increasing the probability that the resulting marketing application will meet regulatory requirement,” says Acting FDA Commissioner Andrew von Eschenbach, MD. “These meetings are a unique aspect of the FDA’s review program, but they are very labor-intensive and require adequate agency resources in order to sustain the current success.” Most products with multiple cycles had major deficiencies identified in only one or two areas. The report also showed, however, that consulting with the FDA prior to application submission does not always prevent the need for multiple review cycles prior to approval.