{"abstract":"The Chief Scientist is denying a request for a hearing regarding the proposal by the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA or Agency) to refuse to approve a new drug application submitted by Pharmaceutical Manufacturing Research Services, Inc. (PMRS) for oxycodone hydrochloride (HCl) immediate-release (IR) capsules, 5 milligrams (mg), 15 mg, and 30 mg in its present form. The Chief Scientist denies approval.","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/2018/10/30/2018-23710.html","cfr_references":[],"citation":"83 FR 54598","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The order is applicable October 30, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-0188"],"dockets":[],"document_number":"2018-23710","effective_on":null,"end_page":54604,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/10/30/2018-23710.xml","html_url":"https://www.federalregister.gov/documents/2018/10/30/2018-23710/denial-of-hearing-request-regarding-proposal-to-refuse-to-approve-a-new-drug-application-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-23710?publication_date=2018-10-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-10-30/2018-23710/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":947,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-10-30/pdf/2018-23710.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-23710.pdf?1540817132","publication_date":"2018-10-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/10/30/2018-23710.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"References Redacted - Clinical Review, Cross-Discipline Deputy Director Review and Summary Division Director Review","document_id":"FDA-2018-N-0188-0293"},{"title":"Reference R - 21-011_Roxicodone_Medr_P2","document_id":"FDA-2018-N-0188-0257"},{"title":"Reference OCR - oxy-pkg","document_id":"FDA-2018-N-0188-0241"},{"title":"Reference OC - 020553_S022_OXYCONTIN_AP","document_id":"FDA-2018-N-0188-0221"},{"title":"Reference ADCOMM - 2017031314-AADPAC_DSaRM-03-Endo_Backgrounder","document_id":"FDA-2018-N-0188-0216"},{"title":"Reference ADCOMM - 2016-11-01 - FDA presentation (CP1)","document_id":"FDA-2018-N-0188-0199"},{"title":"Reference ADCOMM - 2016-09-16 - FDA Transcript","document_id":"FDA-2018-N-0188-0198"},{"title":"Reference - Oxycontin Package Insert","document_id":"FDA-2018-N-0188-0183"},{"title":"Reference - IR REMS - FDA","document_id":"FDA-2018-N-0188-0173"},{"title":"Reference - Highlights of Prescribing Information Roxicodone, December 2016","document_id":"FDA-2018-N-0188-0170"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-N-0188","supporting_documents_count":254,"docket_id":"FDA-2018-N-0188","regulation_id_number":null,"title":"Proposal to Refuse to Approve a New Drug Application for Oxycodone Hydrochloride Immediate-Release Oral Capsules, 5 Milligrams, 15 Milligrams, and 30 Milligrams; Opportunity for a Hearing","checked_regulationsdotgov_at":"2018-11-19T11:00:33Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":54598,"subtype":null,"title":"Denial of Hearing Request Regarding Proposal To Refuse To Approve a New Drug Application for Oxycodone Hydrochloride Immediate-Release Abuse-Deterrent Formulation, Oral Capsules, 5 Milligrams, 15 Milligrams, and 30 Milligrams; Order Refusing Approval","toc_doc":"Denial of Hearing Request Regarding Proposal to Refuse to Approve a New Drug Application for Oxycodone Hydrochloride Immediate-Release Abuse-Deterrent Formulation, Oral Capsules, 5 Milligrams, 15 Milligrams, and 30 Milligrams","toc_subject":"Orders:","topics":[],"type":"Notice","volume":83}