{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled \"Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs.\" This draft guidance is intended to help manufacturers of PET drugs meet the requirements for the Agency's current good manufacturing practice regulations for PET drugs.","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/2011/09/30/2011-25196.html","cfr_references":[],"citation":"76 FR 60847","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 29, 2011.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-D-0691"],"dockets":[],"document_number":"2011-25196","effective_on":null,"end_page":60848,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2011/09/30/2011-25196.xml","html_url":"https://www.federalregister.gov/documents/2011/09/30/2011-25196/draft-guidance-on-media-fills-for-validation-of-aseptic-preparations-for-positron-emission","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2011-25196?publication_date=2011-09-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2011-09-30/2011-25196/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":277,"last_updated":"2026-08-26 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2011-09-30/pdf/2011-25196.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2011-09-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2011/09/30/2011-25196.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-2011-D-0691","supporting_documents_count":0,"docket_id":"FDA-2011-D-0691","regulation_id_number":null,"title":"Draft Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs; Availability","checked_regulationsdotgov_at":"2011-10-20T08:05:45Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":60847,"subtype":null,"title":"Draft Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs; Availability","toc_doc":"Draft Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs; Availability","toc_subject":null,"topics":[],"type":"Notice","volume":76}