{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled \"Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs.\" This 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/2012/04/11/2012-8702.html","cfr_references":[],"citation":"77 FR 21783","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on Agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-D-0691"],"dockets":[],"document_number":"2012-8702","effective_on":null,"end_page":21784,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/04/11/2012-8702.xml","html_url":"https://www.federalregister.gov/documents/2012/04/11/2012-8702/guidance-on-media-fills-for-validation-of-aseptic-preparations-for-positron-emission-tomography","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-8702?publication_date=2012-04-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-04-11/2012-8702/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":995,"last_updated":"2026-06-25 00:15:02 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-04-11/pdf/2012-8702.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-08702.pdf?1334062254","publication_date":"2012-04-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/04/11/2012-8702.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":"2012-05-01T10:01:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":21783,"subtype":null,"title":"Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs; Availability","toc_doc":"Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs","toc_subject":"Guidances; Availability","topics":[],"type":"Notice","volume":77}