{"abstract":"The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry (GFI) #171 entitled \"Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered To Be Soluble in Aqueous Media.\" This 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/2021/05/21/2021-10756.html","cfr_references":[],"citation":"86 FR 27633","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on May 21, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-D-3764"],"dockets":[],"document_number":"2021-10756","effective_on":null,"end_page":27635,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/05/21/2021-10756.xml","html_url":"https://www.federalregister.gov/documents/2021/05/21/2021-10756/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/2021-10756?publication_date=2021-05-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-05-21/2021-10756/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1311,"last_updated":"2026-06-24 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-05-21/pdf/2021-10756.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-10756.pdf?1621514733","publication_date":"2021-05-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/05/21/2021-10756.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-3764-0003","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":"2021-05-26T03:30:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27633,"subtype":null,"title":"Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered To Be Soluble in Aqueous Media; Guidance for Industry; Availability","toc_doc":"Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered to Be Soluble in Aqueous Media","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":86}