federal_register: 2020-25606
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020-25606 | Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act." The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as to describe FDA's interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This draft guidance document provides new Q&As. It does not replace the draft guidance document entitled "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2)," issued December 12, 2018. | 2020-11-20 | 2020 | 11 | https://www.federalregister.gov/documents/2020/11/20/2020-25606/biosimilarity-and-interchangeability-additional-draft-qandas-on-biosimilar-development-and-the | https://www.govinfo.gov/content/pkg/FR-2020-11-20/pdf/2020-25606.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Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act." The question and answer... |