{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is reopening the comment period for the \"Metered Dose Inhaler and Dry Powder Inhaler Drug Products--Quality Considerations; Draft Guidance for Industry,\" published in the Federal Register of April 19, 2018. FDA is reopening the comment period to allow interested persons additional time to submit comments.","action":"Notice; reopening of the comment period.","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/2018/07/20/2018-15508.html","cfr_references":[],"citation":"83 FR 34598","comment_url":null,"comments_close_on":"2018-09-18","correction_of":null,"corrections":[],"dates":"FDA is reopening the comment period on the notice published April 19, 2018 (83 FR 17420). Submit either electronic or written comments by September 18, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-D-1098"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":1,"comment_start_date":"2018-07-20","updated_at":"2023-03-01T01:34:56.530-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-D-1098-0026","allow_late_comments":null,"id":"FDA-2018-D-1098-0026","comment_end_date":"2018-09-19","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2018-D-1098","title":"Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products - Quality Considerations"}],"document_number":"2018-15508","effective_on":null,"end_page":34599,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/07/20/2018-15508.xml","html_url":"https://www.federalregister.gov/documents/2018/07/20/2018-15508/metered-dose-inhaler-and-dry-powder-inhaler-drug-products-quality-considerations-draft-guidance-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-15508?publication_date=2018-07-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-07-20/2018-15508/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":456,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-07-20/pdf/2018-15508.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-15508.pdf?1532004325","publication_date":"2018-07-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/07/20/2018-15508.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":1,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-D-1098","supporting_documents_count":0,"docket_id":"FDA-2018-D-1098","document_id":"FDA-2018-D-1098-0026","regulation_id_number":null,"title":"Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products - Quality Considerations","checked_regulationsdotgov_at":"2023-03-01T06:34:55Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":34598,"subtype":null,"title":"Metered Dose Inhaler and Dry Powder Inhaler Drug Products-Quality Considerations; Draft Guidance for Industry; Reopening of the Comment Period","toc_doc":"Metered Dose Inhaler and Dry Powder Inhaler Drug ProductsQuality Considerations","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}