federal_register: 2020-03505

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2020-03505 Definition of the Term “Biological Product” Rule The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulation that defines "biological product" to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the Further Consolidated Appropriations Act, 2020 (FCA Act), and to provide its interpretation of the statutory term "protein." Under this final rule, the term protein means any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. This final rule is intended to clarify the statutory framework under which such products are regulated. 2020-02-21 2020 2 https://www.federalregister.gov/documents/2020/02/21/2020-03505/definition-of-the-term-biological-product https://www.govinfo.gov/content/pkg/FR-2020-02-21/pdf/2020-03505.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulation that defines "biological product" to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the...

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