federal_register: E9-2881

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

This data as json

document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E9-2881 New Animal Drugs; Bc6 Recombinant Deoxyribonucleic Acid Construct Rule The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of a new animal drug application (NADA) filed by GTC Biotherapeutics, Inc. The NADA provides for use of a recombinant deoxyribonucleic acid (rDNA) construct in a lineage of genetically engineered (GE) goats expressing recombinant human antithrombin in their milk. The subsequently purified antithrombin is a biological product for human therapeutic use. In a separate action, a biologics license application (BLA) has been approved by FDA for use of this antithrombin in humans. 2009-02-11 2009 2 https://www.federalregister.gov/documents/2009/02/11/E9-2881/new-animal-drugs-bc6-recombinant-deoxyribonucleic-acid-construct https://www.govinfo.gov/content/pkg/FR-2009-02-11/pdf/E9-2881.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of a new animal drug application (NADA) filed by GTC Biotherapeutics, Inc. The NADA provides for use of a recombinant deoxyribonucleic acid...

Links from other tables