{"description":"Documents matching 'emideltide'","count":1,"total_pages":1,"results":[{"title":"Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List","type":"Notice","abstract":"The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.","document_number":"2026-07361","html_url":"https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-16/pdf/2026-07361.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07361.pdf?1776257113","publication_date":"2026-04-16","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"}],"excerpts":" \n MOTs-C (free base), MOTs-C acetate \n Obesity and osteoporosis. \n \n \n On July 24, 2026, the Committee will discuss the following bulk drug substances being considered for inclusion on the 503A Bulks List: <span class=\"match\">Emideltide</span> (also referred to as delta sleeping inducing peptide (DSIP))-related bulk drug substances (<span class=\"match\">Emideltide</span> (free base)/<span class=\"match\">Emideltide</span> acetate), Semax-related bulk drug substances (Semax (free base)/Semax acetate), and Epitalon-related bulk drug substances (Epitalon (free base)/Epitalon acetate). The chart below identifies the use(s) FDA reviewed"}]}