{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of two draft guidances for industry entitled \"Labeling for Human Prescription Drug and Biological Products--Implementing the New Content and Format Requirements\" and \"Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products--Content and Format.\" These draft guidances are two of a series of guidance documents intended to assist applicants in complying with the new requirements in the final rule on the content and format of labeling for prescription drug and biological products published elsewhere in this issue of the Federal Register. Elsewhere in this issue of the Federal Register, the agency is announcing the availability of two guidances on the content and format of the \"Clinical Studies\" and \"Adverse Reactions\" sections of labeling.","action":"Notice.","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/2006/01/24/06-543.html","cfr_references":[],"citation":"71 FR 3998","comment_url":null,"comments_close_on":"2006-04-24","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on the draft guidances by April 24, 2006. General comments on agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. 2005D-0011"],"dockets":[],"document_number":"06-543","effective_on":null,"end_page":3999,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2006/01/24/06-543.xml","html_url":"https://www.federalregister.gov/documents/2006/01/24/06-543/draft-guidances-for-industry-on-the-content-and-format-of-labeling-for-human-prescription-drug-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/06-543?publication_date=2006-01-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2006-01-24/06-543/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":187,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2006-01-24/pdf/06-543.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2006-01-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2006/01/24/06-543.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T18:22:54Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":3998,"subtype":null,"title":"Draft Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products; Availability","toc_doc":"New content and format requirements; warnings and precautions, contraindications, etc.; industry guidance","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":71}