{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled \"FDA Oversight of PET Drug Products--Questions and Answers.\" The draft guidance provides questions and answers that address nearly all aspects of the FDA approval and surveillance processes, including application submission, review, compliance with good manufacturing practices, inspections, registration and listing, and user fees.","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/2012/02/27/2012-4427.html","cfr_references":[],"citation":"77 FR 11553","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 29, 2012.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-D-0080"],"dockets":[],"document_number":"2012-4427","effective_on":null,"end_page":11554,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/02/27/2012-4427.xml","html_url":"https://www.federalregister.gov/documents/2012/02/27/2012-4427/draft-guidance-on-food-and-drug-administration-oversight-of-positron-emission-tomography-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-4427?publication_date=2012-02-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-02-27/2012-4427/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":99,"last_updated":"2026-07-27 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-02-27/pdf/2012-4427.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-04427.pdf?1330094338","publication_date":"2012-02-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/02/27/2012-4427.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-D-0080","supporting_documents_count":0,"docket_id":"FDA-2012-D-0080","regulation_id_number":null,"title":"FDA Regulation of PET Drug Products - Questions and Answers; Draft Guidance","checked_regulationsdotgov_at":"2012-05-31T05:00:52Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":11553,"subtype":null,"title":"Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products-Questions and Answers; Availability","toc_doc":"Oversight of Positron Emission Tomography Drug Products","toc_subject":"Draft Guidance; Availability:","topics":[],"type":"Notice","volume":77}