{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled \"Assessment of Pressor Effects of Drugs.\" This draft guidance is intended to advise sponsors on the premarketing assessment of a drug's effect on blood pressure. Elevated blood pressure is known to increase the risk of stroke, heart attack, and death. The effect of a drug on blood pressure is, therefore, an important consideration in risk assessment and product labeling. This draft guidance revises the draft guidance for industry \"Assessment of Pressor Effects of Drugs\" issued on May 31, 2018.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF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/2022/02/04/2022-02371.html","cfr_references":[],"citation":"87 FR 6577","comment_url":null,"comments_close_on":"2022-04-05","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by April 5, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-D-1636"],"dockets":[{"supporting_documents":[{"title":"Assessment of Pressor Effects of Drugs; Revised Draft Guidance for Industry; Availability","document_id":"FDA-2018-D-1636-0010"},{"title":"Assessment of Pressor Effects of Drugs Guidance for Industry Draft Guidance","document_id":"FDA-2018-D-1636-0002"},{"title":"Assessment of Pressor Effects of Drugs; Draft Guidance for Industry; Availability","document_id":"FDA-2018-D-1636-0001"}],"agency_name":null,"documents":[{"comment_count":7,"comment_start_date":"2022-02-04","updated_at":"2023-02-28T12:29:15.862-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-D-1636-0010","allow_late_comments":null,"id":"FDA-2018-D-1636-0010","comment_end_date":"2022-04-06","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":3,"id":"FDA-2018-D-1636","title":"Assessment of Pressor Effects of Drugs; Draft Guidance for Industry; Availability"}],"document_number":"2022-02371","effective_on":null,"end_page":6578,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/02/04/2022-02371.xml","html_url":"https://www.federalregister.gov/documents/2022/02/04/2022-02371/assessment-of-pressor-effects-of-drugs-revised-draft-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-02371?publication_date=2022-02-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-02-04/2022-02371/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":355,"last_updated":"2026-04-04 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-02-04/pdf/2022-02371.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-02371.pdf?1643895930","publication_date":"2022-02-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/02/04/2022-02371.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Assessment of Pressor Effects of Drugs; Revised Draft Guidance for Industry; Availability","document_id":"FDA-2018-D-1636-0010"},{"title":"Assessment of Pressor Effects of Drugs Guidance for Industry Draft Guidance","document_id":"FDA-2018-D-1636-0002"},{"title":"Assessment of Pressor Effects of Drugs; Draft Guidance for Industry; Availability","document_id":"FDA-2018-D-1636-0001"}],"comments_count":7,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-D-1636","supporting_documents_count":3,"docket_id":"FDA-2018-D-1636","document_id":"FDA-2018-D-1636-0010","regulation_id_number":null,"title":"Assessment of Pressor Effects of Drugs; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-02-28T17:29:14Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":6577,"subtype":null,"title":"Assessment of Pressor Effects of Drugs; Revised Draft Guidance for Industry; Availability","toc_doc":"Assessment of Pressor Effects of Drugs","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}