federal_register: 2012-8845

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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
2012-8845 Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI #209; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (draft GFI <greek-i>213) entitled "New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food- Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI <greek-i>209." The purpose of this document is to provide information to sponsors of certain new animal drug products who are interested in developing revised conditions of use for those products consistent with FDA's GFI <greek-i>209, "The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals" and to set timelines for stakeholders wishing to comply voluntarily with this guidance. 2012-04-13 2012 4 https://www.federalregister.gov/documents/2012/04/13/2012-8845/draft-guidance-for-industry-on-new-animal-drugs-and-new-animal-drug-combination-products https://www.govinfo.gov/content/pkg/FR-2012-04-13/pdf/2012-8845.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (draft GFI <greek-i>213) entitled "New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water...  

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