{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Analytical Procedures and Methods Validation for Drugs and Biologics.\" This revised draft guidance supersedes the 2000 draft guidance for industry on \"Analytical Procedures and Methods Validation\" and, when finalized, will also replace the 1987 FDA guidance for industry on \"Submitting Samples and Analytical Data for Methods Validation.\" This draft guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.","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/2014/02/19/2014-03580.html","cfr_references":[],"citation":"79 FR 9467","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 20, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-0103"],"dockets":[],"document_number":"2014-03580","effective_on":null,"end_page":9468,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/02/19/2014-03580.xml","html_url":"https://www.federalregister.gov/documents/2014/02/19/2014-03580/draft-guidance-for-industry-on-analytical-procedures-and-methods-validation-for-drugs-and-biologics","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-03580?publication_date=2014-02-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-02-19/2014-03580/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1917,"last_updated":"2026-08-26 08:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-02-19/pdf/2014-03580.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-03580.pdf?1392731914","publication_date":"2014-02-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/02/19/2014-03580.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2014-03-11T08:10:16Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":9467,"subtype":null,"title":"Draft Guidance for Industry on Analytical Procedures and Methods Validation for Drugs and Biologics; Availability","toc_doc":"Analytical Procedures and Methods Validation for Drugs and Biologics","toc_subject":"Draft Guidance for Industry:","topics":[],"type":"Notice","volume":79}