federal_register: 2021-10603

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2021-10603 Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.'' This guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product that refers to a previously approved peptide drug product of Recombinant Deoxyribonucleic Acid (rDNA) origin should be submitted as an abbreviated new drug application (ANDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) rather than as a new drug application (NDA) under the FD&C Act. This guidance finalizes the draft guidance of the same title issued on October 3, 2017. 2021-05-20 2021 5 https://www.federalregister.gov/documents/2021/05/20/2021-10603/abbreviated-new-drug-applications-for-certain-highly-purified-synthetic-peptide-drug-products-that https://www.govinfo.gov/content/pkg/FR-2021-05-20/pdf/2021-10603.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 final guidance for industry entitled ``ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.'' This guidance is...  

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