{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled \"Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order.\" The existing post-approval studies final guidance, entitled \"Procedures for Handling Post-Approval Studies Imposed by PMA Order,\" was issued in June 2009. This draft guidance is intended to update the 2009 guidance to assist stakeholders with understanding post-approval study requirements imposed as a condition of approval of a premarket approval application (PMA). This draft guidance is not final nor is it in effect at this time.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2021/05/27/2021-11216.html","cfr_references":[],"citation":"86 FR 28630","comment_url":null,"comments_close_on":"2021-07-26","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by July 26, 2021 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2005-D-0027"],"dockets":[{"supporting_documents":[{"title":"Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act; 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Guidance for Industry and Food and Drug Administration Staff - Final Guidance","document_id":"FDA-2005-D-0027-0016"},{"title":"Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff; and Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order; Guidance for Industry and Food and Drug Administration Staff; Availability - Final Guidance","document_id":"FDA-2005-D-0027-0015"},{"title":"Procedures for Handling Post-Approval Studies Imposed by PMA Orders","document_id":"FDA-2005-D-0027-0014"},{"title":"Procedures for Handling Post-Approval Studies Imposed by PMA Order","document_id":"FDA-2005-D-0027-0013"},{"title":"Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order; Draft Guidance for Industry and Food and Drug Administration Staff","document_id":"FDA-2005-D-0027-0006"},{"title":"Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order;\nDraft Guidance for Industry and Food and Drug Administration Staff; Availability","document_id":"FDA-2005-D-0027-0005"},{"title":"FDA","document_id":"FDA-2005-D-0027-0004"},{"title":"Guideline","document_id":"FDA-2005-D-0027-0003"},{"title":"Guidance","document_id":"FDA-2005-D-0027-0002"},{"title":"FDA","document_id":"FDA-2005-D-0027-0001"}],"comments_count":5,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2005-D-0027","supporting_documents_count":10,"docket_id":"FDA-2005-D-0027","document_id":"FDA-2005-D-0027-0005","regulation_id_number":null,"title":"Guidance for Industry and Food and Drug Administration: Procedures for Handling Post-Approval Studies Imposed by PMA Order","checked_regulationsdotgov_at":"2023-02-28T22:35:26Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":28630,"subtype":null,"title":"Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order; Draft","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":86}