{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling.\" This guidance is intended to assist new drug application (NDA) and abbreviated new drug application (ANDA) applicants in submitting an accurate and complete composition statement in their applications and corresponding statement of ingredients in the labeling, when applicable. This guidance describes best practices for writing the composition statement and corresponding statement of ingredients in labeling. This guidance recommends how applicants can provide complete information with the goal of minimizing the number of assessment cycles and communications that are necessary for approval, as well as ensuring product labels are written clearly.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2024/04/29/2024-09156.html","cfr_references":[],"citation":"89 FR 33368","comment_url":null,"comments_close_on":"2024-06-28","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by June 28, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-D-1461"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-04-29","updated_at":"2024-09-03T16:56:07.612-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-D-1461-0001","allow_late_comments":false,"id":"FDA-2024-D-1461-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-D-1461","title":"Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs; Draft Guidance for Industry; Availability"}],"document_number":"2024-09156","effective_on":null,"end_page":33370,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/04/29/2024-09156.xml","html_url":"https://www.federalregister.gov/documents/2024/04/29/2024-09156/content-and-format-of-composition-statement-and-corresponding-statement-of-ingredients-in-labeling","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-09156?publication_date=2024-04-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-04-29/2024-09156/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":486,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-04-29/pdf/2024-09156.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-09156.pdf?1714135544","publication_date":"2024-04-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/04/29/2024-09156.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2024-D-1461","supporting_documents_count":0,"docket_id":"FDA-2024-D-1461","document_id":"FDA-2024-D-1461-0001","regulation_id_number":null,"title":"Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2024-04-30T13:00:25Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":33368,"subtype":null,"title":"Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in New Drug Applications and Abbreviated New Drug Applications; Draft Guidance for Industry; Availability","toc_doc":"Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in New Drug Applications and Abbreviated New Drug Applications","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":89}