{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.\" This draft guidance responds to stakeholder requests for specific guidance on FDA's current views on how manufacturers, packers, and distributors (firms), that may either be the applicant or acting on behalf of the applicant, of prescription human and animal drug and biological products (drugs) can fulfill regulatory requirements for postmarketing submissions of interactive promotional media for their FDA-approved products. This draft guidance clarifies FDA's policies on what the Agency considers to be interactive promotional media.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH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/2014/01/14/2014-00519.html","cfr_references":[],"citation":"79 FR 2449","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on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 14, 2014. General comments on Agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-1430"],"dockets":[],"document_number":"2014-00519","effective_on":null,"end_page":2450,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/01/14/2014-00519.xml","html_url":"https://www.federalregister.gov/documents/2014/01/14/2014-00519/draft-guidance-for-industry-on-fulfilling-regulatory-requirements-for-postmarketing-submissions-of","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-00519?publication_date=2014-01-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-01-14/2014-00519/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1556,"last_updated":"2026-07-26 08:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-01-14/pdf/2014-00519.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-00519.pdf?1389621278","publication_date":"2014-01-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/01/14/2014-00519.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2014-02-19T05:15:20Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":2449,"subtype":null,"title":"Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics; Availability","toc_doc":"Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics","toc_subject":"Draft Guidance for Industry and Staff; Availability:","topics":[],"type":"Notice","volume":79}