{"abstract":"The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry (GFI) #171 entitled \"Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media.\" This draft guidance describes how the Agency intends to evaluate requests for waiving the requirement for performing in vivo bioequivalence studies for animal drugs administered orally as soluble powders or as Type A medicated articles manufactured from active pharmaceutical ingredients considered to be soluble in aqueous media.","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/2019/09/30/2019-21202.html","cfr_references":[],"citation":"84 FR 51595","comment_url":null,"comments_close_on":"2019-11-29","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by November 29, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2019-D-3764"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2019-09-30","updated_at":"2023-02-28T21:01:06.051-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2019-D-3764-0001","allow_late_comments":null,"id":"FDA-2019-D-3764-0001","comment_end_date":"2019-11-30","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2019-D-3764","title":"Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media; Draft Guidance for Industry; Availability "}],"document_number":"2019-21202","effective_on":null,"end_page":51597,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/09/30/2019-21202.xml","html_url":"https://www.federalregister.gov/documents/2019/09/30/2019-21202/demonstrating-bioequivalence-for-soluble-powder-oral-dosage-form-products-and-type-a-medicated","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-21202?publication_date=2019-09-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-09-30/2019-21202/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":404,"last_updated":"2026-07-26 14:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-09-30/pdf/2019-21202.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-21202.pdf?1569588329","publication_date":"2019-09-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/09/30/2019-21202.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-2019-D-3764","supporting_documents_count":0,"docket_id":"FDA-2019-D-3764","document_id":"FDA-2019-D-3764-0001","regulation_id_number":null,"title":"Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media; Draft Guidance for Industry; Availability ","checked_regulationsdotgov_at":"2023-03-01T02:01:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":51595,"subtype":null,"title":"Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured From Active Pharmaceutical Ingredients Considered To Be Soluble in Aqueous Media; Draft Guidance for Industry; Availability","toc_doc":"Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":84}