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FDA Loosens Sterility Testing Rules For Biologics

Law360, New York (May 2, 2012, 4:05 PM EDT) -- The U.S. Food and Drug Administration on Wednesday issued a final rule that will allow biologic drugmakers to choose their own tests to make sure their products are sterile, a departure from past rules that mandated the use of specific sterility tests.

The agency said the new rule will provide biologics makers with much more flexibility and allow them to use methods that are newer and often faster than the tests prescribed by the FDA in the past. Biologics, because they are made using living cells,...
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