{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.\" This guidance discusses FDA recommendations for the size, shape, and other physical attributes of generic tablets intended to be swallowed intact. FDA is concerned that these characteristics of generic drugs are too varied compared to the originator drug and could affect patient outcomes.","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/2013/12/10/2013-29395.html","cfr_references":[],"citation":"78 FR 74154","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 10, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-1434"],"dockets":[],"document_number":"2013-29395","effective_on":null,"end_page":74154,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/12/10/2013-29395.xml","html_url":"https://www.federalregister.gov/documents/2013/12/10/2013-29395/draft-guidance-for-industry-on-size-shape-and-other-physical-attributes-of-generic-tablets-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-29395?publication_date=2013-12-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-12-10/2013-29395/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":893,"last_updated":"2026-04-05 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-12-10/pdf/2013-29395.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-29395.pdf?1386597277","publication_date":"2013-12-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/12/10/2013-29395.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2014-02-19T05:02:33Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":74154,"subtype":null,"title":"Draft Guidance for Industry on Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules; Availability","toc_doc":"Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules","toc_subject":"Draft Guidance for Industry:","topics":[],"type":"Notice","volume":78}