federal_register: 2021-15170

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2021-15170 Product-Specific Guidance for Cilastatin Sodium; Imipenem; Relebactam; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Draft Guidance for Cilastatin Sodium; Imipenem; Relebactam." The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for cilastatin sodium; imipenem; relebactam for injection. 2021-07-19 2021 7 https://www.federalregister.gov/documents/2021/07/19/2021-15170/product-specific-guidance-for-cilastatin-sodium-imipenem-relebactam-draft-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2021-07-19/pdf/2021-15170.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Draft Guidance for Cilastatin Sodium; Imipenem; Relebactam." The draft guidance, when finalized, will provide product-specific...

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