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www.fdanews.com/articles/122275-fda-extends-comment-period-on-combination-products-rule

FDA Extends Comment Period on Combination Products Rule

November 17, 2009
Requests from stakeholders have led the FDA to extend the comment period to Feb. 5 on a proposed rule on good manufacturing practices (GMPs) for combination products. Under the proposed rule, companies could develop written procedures for a streamlined system to show compliance with GMPs for drugs or biologics and quality system requirements for devices.
Washington Drug Letter