federal_register: 2018-26840

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2018-26840 Definition of the Term “Biological Product” Proposed Rule The Food and Drug Administration (FDA or the Agency) is proposing 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 to provide its interpretation of the statutory terms "protein" and "chemically synthesized polypeptide." Under that interpretation, the term protein would mean any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. A chemically synthesized polypeptide would mean any alpha amino acid polymer that is made entirely by chemical synthesis and is greater than 40 amino acids but less than 100 amino acids in size. This proposed rule is intended to clarify the statutory framework under which such products are regulated. 2018-12-12 2018 12 https://www.federalregister.gov/documents/2018/12/12/2018-26840/definition-of-the-term-biological-product https://www.govinfo.gov/content/pkg/FR-2018-12-12/pdf/2018-26840.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or the Agency) is proposing 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 to provide its...

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