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FDA issues final rule on sterility testing of biological products
date:May 04, 2012
The U.S. Food and Drug Administration issued its final rule on sterility testing, amending the requirements for most licensed biological products. The action follows a retrospective review of agency regulations to promote improvement and innovation and is in response to Executive Order 13563 that is designed to improve regulation and regulatory review.
The FDA recognizes the role innovation plays in bringing safe and effective products to market in a timely and cost-efficient manner. This action

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