FDA Wants Relaxed Sterility Test Rules For Bio Products

Law360, New York (June 21, 2011, 7:40 PM EDT) -- The U.S. Food and Drug Administration on Tuesday rolled out a proposal to update and loosen sterility test requirements for biological products like vaccines and stem-cell treatments, as part of efforts to maintain current biologics regulations.

The FDA is proposing modifications to regulations that ensure biological products are sterile and free of microorganisms. The proposed amendments are aimed at the testing of some novel products that could be introduced to the market, currently approved products, and encouraging manufacturers to adopt the latest test methods, according to...
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