federal_register: 2012-10649

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2012-10649 Amendments to Sterility Test Requirements for Biological Products Rule The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This 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. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products. 2012-05-03 2012 5 https://www.federalregister.gov/documents/2012/05/03/2012-10649/amendments-to-sterility-test-requirements-for-biological-products https://www.govinfo.gov/content/pkg/FR-2012-05-03/pdf/2012-10649.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and...

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