{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Transdermal and Topical Delivery Systems--Product Development and Quality Considerations.\" This guidance provides recommendations to applicants and manufacturers of transdermal and topical delivery systems (TDS) regarding the pharmaceutical development and quality information to include in new drug applications (NDAs) and abbreviated new drug applications (ANDAs). Specifically, the guidance discusses FDA's current thinking on product design and pharmaceutical development, manufacturing process and control, and finished product control. It also addresses special considerations for areas where quality is closely tied to product performance and potential safety issues, such as adhesion failure and the impact of applied heat on drug delivery.","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/2019/11/21/2019-25246.html","cfr_references":[],"citation":"84 FR 64319","comment_url":null,"comments_close_on":"2020-02-19","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by February 19, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-4447"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":18,"comment_start_date":"2019-11-21","updated_at":"2023-03-01T00:27:43.598-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2019-D-4447-0001","allow_late_comments":null,"id":"FDA-2019-D-4447-0001","comment_end_date":"2020-02-20","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2019-D-4447","title":"Transdermal and Topical Delivery Systems - Product Development and Quality Considerations; Draft Guidance for Industry; Availability"}],"document_number":"2019-25246","effective_on":null,"end_page":64321,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/11/21/2019-25246.xml","html_url":"https://www.federalregister.gov/documents/2019/11/21/2019-25246/transdermal-and-topical-delivery-systems-product-development-and-quality-considerations-draft","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-25246?publication_date=2019-11-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-11-21/2019-25246/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1593,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-11-21/pdf/2019-25246.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-25246.pdf?1574257520","publication_date":"2019-11-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/11/21/2019-25246.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":18,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2019-D-4447","supporting_documents_count":0,"docket_id":"FDA-2019-D-4447","document_id":"FDA-2019-D-4447-0001","regulation_id_number":null,"title":"Transdermal and Topical Delivery Systems - Product Development and Quality Considerations; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-03-01T05:27:42Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":64319,"subtype":null,"title":"Transdermal and Topical Delivery Systems-Product Development and Quality Considerations; Draft Guidance for Industry; Availability","toc_doc":"Transdermal and Topical Delivery SystemsProduct Development and Quality Considerations","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":84}