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www.fdanews.com/articles/123772-expert-navigating-import-challenge-doesn-t-stop-at-compliance-officers

Expert: Navigating Import Challenge Doesn't Stop at Compliance Officers

January 18, 2010
Drug companies have several courses of action when negotiating the release of a product entering the U.S. that has been challenged by an FDA compliance officer, Benjamin England, an attorney with consulting firm FDA Imports, says. Agency compliance officers may request information they don’t have the authority to require, such as an end-user letter, before releasing a product, England said during an FDAnews webinar. If the FDA won’t release a shipment in this situation and the company can’t or doesn’t want to provide the document, it should file an appeal seeking an internal review of the decision, he advised.
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