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Zdrowie i gospodarka · 24.05.2012

Amendments to Sterility Test Requirements for Biological Products; Correction

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of May 3, 2012. (77 FR 26162). The final rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The rule was published with an inaccurate citation in the codified section of the rule. This notice corrects that error.

Source: Federal Register — Food and Drug AdministrationOpen original release →