{"description":"Documents matching 'peptide' and from Food and Drug Administration","count":104,"total_pages":6,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bagencies%5D%5B%5D=food-and-drug-administration&conditions%5Bterm%5D=peptide&format=json&page=2","results":[{"title":"Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products; Reopening of the Comment Period","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the request for information and comments notice entitled \"Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products,\" published in the Federal Register of July 25, 2024. FDA is reopening the comment period to update comments and to receive any new information.","document_number":"2024-31365","html_url":"https://www.federalregister.gov/documents/2024/12/31/2024-31365/evaluating-the-immunogenicity-risk-of-host-cell-proteins-in-follow-on-recombinant-peptide-products","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-31/pdf/2024-31365.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31365.pdf?1735566318","publication_date":"2024-12-31","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":"of the comment period. \n \n \n SUMMARY: \n \n The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the request for information and comments notice entitled “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant <span class=\"match\">Peptide</span> Products,” published in the \n Federal Register \n of July 25, 2024. FDA is reopening the comment period to update comments and to receive any new information.\n \n \n \n DATES: \n FDA is reopening the comment period on the request for information and comments notice published July"},{"title":"Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products; Establishment of a Public Docket; Request for Information and Comments","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect information and comments on evaluating and mitigating the immunogenicity risk of host cell proteins (HCPs). For the purpose of this request, FDA is specifically interested in comments on suitable methods to detect, identify, and quantify HCPs, on achievable residual amounts of HCPs for recombinant peptide products, and on the use of in vitro, in silico immunogenicity assessment (IVISIA) of HCPs in a recombinant peptide (rPeptide) product. For the purpose of this request, a \"follow-on\" peptide product refers to the applications currently evaluated through the 505(b)(2) pathway. Although follow-on recombinant peptide products can rely on FDA's findings of safety and effectiveness for a listed drug that is a peptide product, differences in recombinant expression systems used during the peptide production could result in quality attribute differences, including in the HCP profile, which in turn, could contribute to differences in immunogenicity risks between a follow-on recombinant peptide product and the listed drug. The public comments collected will help FDA develop recommendations on how HCP control and characterization can support comparative immunogenicity risk assessment between a recombinant follow-on peptide and the listed product.","document_number":"2024-16356","html_url":"https://www.federalregister.gov/documents/2024/07/25/2024-16356/evaluating-the-immunogenicity-risk-of-host-cell-proteins-in-follow-on-recombinant-peptide-products","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-07-25/pdf/2024-16356.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-16356.pdf?1721825130","publication_date":"2024-07-25","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":"of HCPs for recombinant <span class=\"match\">peptide</span> products, and on the use of in vitro, in silico immunogenicity assessment (IVISIA) of HCPs in a recombinant <span class=\"match\">peptide</span> (rPeptide) product. For the purpose of this request, a “follow-on” <span class=\"match\">peptide</span> product refers to the applications currently evaluated through the 505(b)(2) pathway. Although follow-on recombinant <span class=\"match\">peptide</span> products can rely on FDA's findings of safety and effectiveness for a listed drug that is a <span class=\"match\">peptide</span> product, differences in recombinant expression systems used during the <span class=\"match\">peptide</span> production could result"},{"title":"Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document titled \"Potency Assessment of Active Immunotherapy Products.\" The draft guidance document provides recommendations for developing assays to assess potency as a part of a potency assurance strategy for active immunotherapy products (ACTIMPs). When finalized, this guidance will describe the FDA's current thinking regarding design, validation, and evaluation of potency tests for ACTIMPs. This guidance is intended to supplement the December 2023 draft guidance for industry, when finalized, on \"Potency Assurance for Cellular and Gene Therapy Products\" with additional advice and considerations specifically for ACTIMPs, including peptide- and-protein based ACTIMPs that are not cellular or gene therapy products.","document_number":"2026-16960","html_url":"https://www.federalregister.gov/documents/2026/08/20/2026-16960/potency-assessment-of-active-immunotherapy-products-draft-guidance-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-20/pdf/2026-16960.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16960.pdf?1787143517","publication_date":"2026-08-20","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":"of potency tests for ACTIMPs. This guidance is intended to supplement the December 2023 draft guidance for industry, when finalized, on “Potency Assurance for Cellular and Gene Therapy Products” with additional advice and considerations specifically for ACTIMPs, including <span class=\"match\">peptide</span>- and-protein based ACTIMPs that are not cellular or gene therapy products. \n \n \n DATES: \n Submit either electronic or written comments on the draft guidance by November 18, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work"},{"title":"Clinical Pharmacology Considerations for Peptide Drug Products; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Clinical Pharmacology Considerations for Peptide Drug Products.\" This guidance describes FDA's recommendations regarding clinical pharmacology considerations for peptide drug product development programs, including hepatic impairment, drug-drug interactions (DDIs), assessing QTc prolongation risk, and immunogenicity risk and impact on the pharmacokinetics (PK), safety, and efficacy assessment. The intent of this draft guidance, when finalized, is to assist industry in the conduct of these development programs.","document_number":"2023-19456","html_url":"https://www.federalregister.gov/documents/2023/09/11/2023-19456/clinical-pharmacology-considerations-for-peptide-drug-products-draft-guidance-for-industry","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-09-11/pdf/2023-19456.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-19456.pdf?1694177179","publication_date":"2023-09-11","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 FDA is announcing the availability of a draft guidance for industry entitled “Clinical Pharmacology Considerations for <span class=\"match\">Peptide</span> Drug Products.” This draft guidance, when finalized, will represent FDA's current thinking on the conduct of certain clinical pharmacology studies during the development of <span class=\"match\">peptide</span> drug products. \n The term “<span class=\"match\">peptide</span>” refers to any polymer composed of 40 or fewer amino acids. In general, if a <span class=\"match\">peptide</span> meets the definition of a drug and does not otherwise meet the statutory definition of a “biological product” or a “device"},{"title":"Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue","type":"Rule","abstract":"The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of gardenia (genipin) blue in various foods, at levels consistent with good manufacturing practice (GMP). We are taking this action in response to a color additive petition (CAP) submitted by Exponent, Inc., on behalf of the Gardenia Blue Interest Group (GBIG).","document_number":"2025-13175","html_url":"https://www.federalregister.gov/documents/2025/07/15/2025-13175/listing-of-color-additives-exempt-from-certification-gardenia-genipin-blue","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-15/pdf/2025-13175.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-13175.pdf?1752497107","publication_date":"2025-07-15","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":"the genipin-<span class=\"match\">peptide</span> polymer (the principal coloring component). Assuming a maximum content of 40 percent of the genipin-<span class=\"match\">peptide</span> polymer in the color additive, the petitioner estimated an eaters-only dietary exposure to the principal coloring component from the proposed uses to be 13 mg/p/d at the mean and 29 mg/p/d at the 90th percentile for the U.S. population aged 2 years and older and for children 2-5 years (Ref. 2). We concur with this approach to estimating the dietary exposure to both the color additive and the genipin-<span class=\"match\">peptide</span> polymer content"},{"title":"List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (the 503B Bulks List). This notice identifies three bulk drug substances that FDA has considered and proposes not to include on the 503B Bulks List: semaglutide, tirzepatide, and liraglutide. Additional bulk drug substances nominated for inclusion on this list are under consideration and may be the subject of future notices.","document_number":"2026-08552","html_url":"https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-01/pdf/2026-08552.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08552.pdf?1777553125","publication_date":"2026-05-01","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":"administration present challenges. The article “describes the current state of the art with respect to the creation of nanoparticles containing <span class=\"match\">peptides</span> such as insulin, glucagon-like <span class=\"match\">peptide</span> 1 (GLP-1), and their agonists, and theorizes the production of mucoadhesive unidirectional release buccal tablets or films.” The paper identifies potential “challenges” that could emerge with the development of new formulations of <span class=\"match\">peptide</span> drugs that could be administered via non-parenteral routes of administration for the treatment of diabetes mellitus (\n e.g., \n insulin"},{"title":"Product-Specific Guidances; Revised Draft Guidances for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of additional revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled \"Bioequivalence Recommendations for Specific Products\" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.","document_number":"2026-15285","html_url":"https://www.federalregister.gov/documents/2026/07/29/2026-15285/product-specific-guidances-revised-draft-guidances-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-29/pdf/2026-15285.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-15285.pdf?1785242713","publication_date":"2026-07-29","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":"announced in the \n Federal Register \n on May 22, 2026 (91 FR 30307). This notice announces revised draft product-specific guidances that are posted on FDA's website.\n \n FDA is also withdrawing the guidance for industry entitled “ANDAs for Certain Highly Purified Synthetic <span class=\"match\">Peptide</span> Drug Products That Refer to Listed Drugs of rDNA Origin” (May 2021) as it no longer reflects FDA's current scientific thinking. As noted in the Center for Drug Evaluation and Research guidance agenda, FDA plans to revise and reissue the guidance this year. \n II. Drug Products"},{"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":"healing. \n \n \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: Emideltide (also referred to as delta sleeping inducing <span class=\"match\">peptide</span> (DSIP))-related bulk drug substances (Emideltide (free base)/Emideltide 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)"},{"title":"Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract","type":"Rule","abstract":"The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of butterfly pea flower extract as a color additive in ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), and plain corn chips, tortilla chips, and multigrain chips at levels consistent with good manufacturing practice (GMP). This action is in response to a color additive petition (CAP) submitted by Sensient Colors, LLC (Sensient or petitioner).","document_number":"2025-08248","html_url":"https://www.federalregister.gov/documents/2025/05/12/2025-08248/listing-of-color-additives-exempt-from-certification-butterfly-pea-flower-extract","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-05-12/pdf/2025-08248.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-08248.pdf?1746794720","publication_date":"2025-05-12","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":"hypersensitive reactions. The petitioner submitted an updated search of the peer-reviewed scientific literature and found no new additional publications which suggested an allergenicity concern. Further, to mitigate the possible risk that allergenic proteins and other large <span class=\"match\">peptides</span> might pose, our regulation at 21 CFR 73.69(a)(1) requires that the aqueous extract used to produce the color additive undergo ultrafiltration. Therefore, we concluded that butterfly pea flower extract presents an insignificant allergy risk to consumers of the color additive"},{"title":"Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Creams, or Ointment; and Liquid Wound Washes","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA, Agency, or we) are proposing to classify certain types of wound dressings and liquid wound washes containing antimicrobials and/or other chemicals (unclassified, preamendments devices) as solid wound dressings; wound dressings formulated as a gel, cream, or ointment; and liquid wound washes. FDA currently regulates these unclassified devices as devices requiring premarket notification (510(k) requirements), with the product codes FRO, GER, MGP, MGQ, and EFQ, but FDA intends to create new product codes for these proposed classifications upon finalization of this classification action. FDA is proposing to classify certain wound dressings and liquid wound washes containing antimicrobials with a high level of antimicrobial resistance (AMR) concern (i.e., medically important antimicrobials) into class III. In addition, FDA is proposing to classify certain wound dressings and liquid wound washes containing antimicrobials with a medium or low level of AMR concern and/or other chemicals, into class II (subject to special controls and 510(k) requirements).","document_number":"2023-26209","html_url":"https://www.federalregister.gov/documents/2023/11/30/2023-26209/medical-devices-general-and-plastic-surgery-devices-classification-of-certain-solid-wound-dressings","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-11-30/pdf/2023-26209.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-26209.pdf?1701265528","publication_date":"2023-11-30","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":"oil, cod liver oil, white petrolatum, lanolin, glycerin, dimethicone, lanolin, allantoin, zinc oxide, aluminum hydroxide, calamine, sodium bicarbonate, zinc acetate, zinc carbonate. \n \n \n Honey \n Manuka honey, buckwheat honey. \n \n \n Synthetic <span class=\"match\">Peptides</span> \n RADA16 (RADARADARADARADA) <span class=\"match\">peptide</span>, self-assembling <span class=\"match\">peptides</span>. \n \n \n Botanical Extracts \n Olive oil, grape seed extract, aloe, lavender, tea tree oil, vegetable oil, shea butter, sesame oil. \n \n \n 5. Animal-Derived Materials \n Solid wound dressings, wound dressings formulated as a gel, cream, or ointment"},{"title":"Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments","type":"Notice","abstract":"The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee (the Committee). The general function of the Committee as a medical device panel is to provide advice and recommendations to FDA. In addition, the Committee will meet to discuss and provide advice to FDA on in vitro diagnostic devices used in pandemic preparedness and response to satisfy, in part, a requirement under the Food and Drug Omnibus Reform Act of 2022 (FDORA). The meeting will be open to the public. FDA is establishing a docket for public comment on this document.","document_number":"2023-17287","html_url":"https://www.federalregister.gov/documents/2023/08/14/2023-17287/microbiology-devices-panel-of-the-medical-devices-advisory-committee-notice-of-meeting-establishment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-08-14/pdf/2023-17287.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-17287.pdf?1691757922","publication_date":"2023-08-14","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":"session III, will discuss and make recommendations regarding a potential future reclassification from class III to class II with special controls of cell-mediated immune reactivity in vitro diagnostic devices indicated for use to aid in identification of in vitro responses to <span class=\"match\">peptide</span> antigens that are associated with \n Mycobacterium tuberculosis \n infection and/or for use as detection of effector T cells that respond to stimulation by \n M. tuberculosis \n agents.\n \n All devices to be discussed by the Committee on September 7, 2023, are postamendments devices"},{"title":"Scientific Challenges and Opportunities To Advance the Development of Individualized Cellular and Gene Therapies; Request for Information","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency), Center for Biologics Evaluation and Research (CBER) is requesting information from stakeholders regarding critical scientific challenges and opportunities to advance the development of individualized cellular and gene therapies (CGTs). FDA intends to gather information and comments submitted in response to this request for information (RFI) to inform potential planning of future town halls, workshops, or discussion papers which could ultimately facilitate the development of additional regulatory science tools, standards, or guidance.","document_number":"2023-20452","html_url":"https://www.federalregister.gov/documents/2023/09/21/2023-20452/scientific-challenges-and-opportunities-to-advance-the-development-of-individualized-cellular-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-09-21/pdf/2023-20452.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-20452.pdf?1695213961","publication_date":"2023-09-21","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":"Examples of these emerging areas of research include: \n • Products designed for the same indication with the same mode of action. For instance, a personalized vaccine for pancreatic cancer that consists of autologous dendritic cells pulsed with patient-specific neoantigen <span class=\"match\">peptides</span> (Ref. 5). \n • Products designed for different indications with different modes of action. For instance, two gene therapy vector products for separate rare genetic neurological diseases, where both products utilize the same vector backbone but contain different transgene"},{"title":"Final Decision on the Proposal To Refuse To Approve a New Drug Application for ITCA 650","type":"Notice","abstract":"The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) refusing to approve a new drug application (NDA) submitted by Intarcia Therapeutics, Inc., an i2o Therapeutics Business Unit, (Intarcia) for ITCA 650 (exenatide in DUROS device). FDA has determined that the approval criteria in the FD&C Act have not been met because Intarcia has failed to demonstrate that ITCA 650 is safe for its intended conditions of use.","document_number":"2024-18898","html_url":"https://www.federalregister.gov/documents/2024/08/23/2024-18898/final-decision-on-the-proposal-to-refuse-to-approve-a-new-drug-application-for-itca-650","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-23/pdf/2024-18898.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-18898.pdf?1724330720","publication_date":"2024-08-23","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":"Spring, MD 20993, 240-402-5931. \n \n \n \n SUPPLEMENTARY INFORMATION: \n I. Factual and Procedural Background \n ITCA 650 (exenatide in DUROS device) is a novel drug-device combination product for human patients intended to deliver the active ingredient, exenatide, a glucagon-like <span class=\"match\">peptide</span>-1 receptor agonist (GLP-1 RA). Intarcia proposed that ITCA 650 be indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ITCA 650 is intended to provide continuous dosing of exenatide from an osmotic mini-pump implanted"},{"title":"Evaluating the Clinical Pharmacology of Peptides; Establishment of a Public Docket; Request for Information and Comments","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect comments on evaluating the clinical pharmacology of peptides. For the purpose of this request, FDA is specifically interested in comments regarding the characterization of the effects of hepatic impairment, drug-drug interactions, and immunogenicity on the pharmacokinetics of peptides, as well as the effects of peptides on cardiac electrophysiology. However, there may be other clinical pharmacology considerations concerning the development of peptides. Public comments will help FDA develop recommendations for the design and conduct of studies important to the safe and effective use of peptides and facilitate the regulatory assessment of such studies.","document_number":"2021-10179","html_url":"https://www.federalregister.gov/documents/2021/05/14/2021-10179/evaluating-the-clinical-pharmacology-of-peptides-establishment-of-a-public-docket-request-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-05-14/pdf/2021-10179.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-10179.pdf?1620909927","publication_date":"2021-05-14","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":"public docket to collect comments on evaluating the clinical pharmacology of <span class=\"match\">peptides</span>. For the purpose of this request, FDA is specifically interested in comments regarding the characterization of the effects of hepatic impairment, drug-drug interactions, and immunogenicity on the pharmacokinetics of <span class=\"match\">peptides</span>, as well as the effects of <span class=\"match\">peptides</span> on cardiac electrophysiology. However, there may be other clinical pharmacology considerations concerning the development of <span class=\"match\">peptides</span>. Public comments will help FDA develop recommendations for the design and"},{"title":"Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.'' This guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product that refers to a previously approved peptide drug product of Recombinant Deoxyribonucleic Acid (rDNA) origin should be submitted as an abbreviated new drug application (ANDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) rather than as a new drug application (NDA) under the FD&C Act. This guidance finalizes the draft guidance of the same title issued on October 3, 2017.","document_number":"2021-10603","html_url":"https://www.federalregister.gov/documents/2021/05/20/2021-10603/abbreviated-new-drug-applications-for-certain-highly-purified-synthetic-peptide-drug-products-that","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-05-20/pdf/2021-10603.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-10603.pdf?1621428326","publication_date":"2021-05-20","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":"Synthetic <span class=\"match\">Peptide</span> Drug Products That Refer to Listed Drugs of rDNA Origin.” This guidance is intended to assist potential applicants in determining when an application for a synthetic <span class=\"match\">peptide</span> drug product that refers to a previously approved <span class=\"match\">peptide</span> drug product of rDNA origin should be submitted as an ANDA under section 505(j) of the FD&amp;C Act (21 U.S.C. 355(j)) rather than as an NDA under section 505(b) of the FD&amp;C Act. \n This guidance finalizes the draft guidance entitled “ANDAs for Certain Highly Purified Synthetic <span class=\"match\">Peptide</span> Drug Products"},{"title":"List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is developing a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies two bulk drug substances that FDA has considered and proposes to include on the 503B Bulks List to compound three categories of compounded drug products: arginine hydrochloride (HCl) for oral use, lysine HCl for oral use, and lysine HCl for intravenous use in combination with FDA-approved, single-ingredient arginine HCl for intravenous use. This notice identifies three bulk drug substances that FDA has considered and proposes not to include on the 503B Bulks List: etomidate, furosemide, and rocuronium bromide. Additional bulk drug substances nominated for inclusion on this list are under consideration and may be the subject of future notices.","document_number":"2022-25549","html_url":"https://www.federalregister.gov/documents/2022/11/23/2022-25549/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-11-23/pdf/2022-25549.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-25549.pdf?1669124731","publication_date":"2022-11-23","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":"Single-Ingredient Arginine HCl \n \n Lysine HCl was also nominated for the 503B Bulks List both as a single-ingredient and in combination with arginine HCl.\n 30 31 \n \n Lysine HCl was nominated to compound single-ingredient drug products that are used for reduction of radiolabeled <span class=\"match\">peptides</span> during <span class=\"match\">peptide</span> receptor radionuclide therapy (PRRT).\n 32 \n \n Lysine HCl in combination with arginine HCl was nominated for post-LUTATHERA \n 33 \n \n treatment. LUTATHERA is indicated to treat somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut"},{"title":"Patrick Charles Bishop: Final Debarment Order","type":"Notice","abstract":"The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Patrick Charles Bishop for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Bishop was convicted of one felony count under Federal law for conspiracy to commit fraud. The factual basis supporting Mr. Bishop's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Bishop was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. Mr. Bishop provided notice to FDA that he acquiesced to the debarment; FDA received that notice on January 4, 2022. As such, his debarment commenced on the date FDA was notified of acquiescence.","document_number":"2022-04469","html_url":"https://www.federalregister.gov/documents/2022/03/03/2022-04469/patrick-charles-bishop-final-debarment-order","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-03-03/pdf/2022-04469.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-04469.pdf?1646228728","publication_date":"2022-03-03","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":"conviction referenced herein. The factual basis for this conviction is as follows: As contained in the plea agreement in Mr. Bishop's case, filed on January 7, 2021, in which he pleaded guilty, he owned Patrick, LLC and employed other individuals. Using the business name “Best <span class=\"match\">Peptide</span> Supply, LLC,” he ordered PNC-27 from GL Biochem (Shanghai), Ltd., a supplier based in China, and used the PNC-27 to manufacture drug products intended for the treatment of cancer in humans. FDA has not approved PNC-27 for use in the United States as a drug to treat any disease"},{"title":"International Dairy Foods Association and Chobani, Inc.: Response to the Objections and Requests for a Public Hearing on the Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt","type":"Rule","abstract":"The Food and Drug Administration (FDA, Agency, or we) received objections and requests for a hearing from the International Dairy Foods Association (IDFA) and Chobani, Inc. (Chobani) on the final rule titled \"Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt,\" which published on June 11, 2021. The final rule revoked the standards of identity for lowfat yogurt and nonfat yogurt and amended the standard of identity for yogurt in numerous respects. We are denying the requests for a public hearing and modifying the final rule in response to certain objections. Therefore, the stay of the effectiveness for the final regulation is now lifted.","document_number":"2022-27040","html_url":"https://www.federalregister.gov/documents/2022/12/15/2022-27040/international-dairy-foods-association-and-chobani-inc-response-to-the-objections-and-requests-for-a","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-12-15/pdf/2022-27040.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-27040.pdf?1671025515","publication_date":"2022-12-15","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":"protein are subject to action by yogurt cultures during fermentation and impact the characteristics of yogurt. IDFA states, on page 6 of its objection, that “addition of milk and milk-derived ingredients that contain significant amounts of lactose, proteins and amino acid <span class=\"match\">peptides</span>, which are indeed subjected to action by yogurt cultures during fermentation, do play a role in providing the unique organoleptic characteristics of yogurt.” IDFA further states, on page 7, that “the main contribution to the unique flavor and aroma of plain, unflavored yogurt"},{"title":"Determination That SANDOSTATIN (Octreotide Acetate) Injection, Equal to 0.2 Milligrams Base/Milliliter and Equal to 1 Milligrams Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) has determined that SANDOSTATIN (octreotide acetate) injection, equal to (EQ) 0.2 milligrams (mg) base/milliliter (mL) and 1 mg base/mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.","document_number":"2021-11575","html_url":"https://www.federalregister.gov/documents/2021/06/02/2021-11575/determination-that-sandostatin-octreotide-acetate-injection-equal-to-02-milligrams-basemilliliter","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-06-02/pdf/2021-11575.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-11575.pdf?1622551542","publication_date":"2021-06-02","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":"treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. SANDOSTATIN is also indicated for the treatment of profuse watery diarrhea associated with vasoactive intestinal <span class=\"match\">peptide</span>-secreting tumors. \n In a letter received by the Agency on May 11, 2020, Novartis Pharmaceuticals Corporation notified FDA that SANDOSTATIN (octreotide acetate) injection, EQ 0.2 mg base/mL and EQ 1 mg base/mL, was being discontinued, and FDA moved the drug product to the"},{"title":"Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract","type":"Rule","abstract":"The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of an aqueous extract of butterfly pea flower (Clitoria ternatea) as a color additive in various food categories at levels consistent with good manufacturing practice. We are taking this action in response to a color additive petition (CAP) submitted by Exponent, Inc., on behalf of Sensient Colors, LLC (Sensient).","document_number":"2021-18995","html_url":"https://www.federalregister.gov/documents/2021/09/02/2021-18995/listing-of-color-additives-exempt-from-certification-butterfly-pea-flower-extract","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-09-02/pdf/2021-18995.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-18995.pdf?1630500335","publication_date":"2021-09-02","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":"identity over an 80-amino-acid sliding window); however, these proteins are expected to be over 5,000 Da and not likely to pass through the 2,500 Da ultrafiltration system used in the manufacturing process. To mitigate the possible risk that allergenic proteins and other large <span class=\"match\">peptides</span> might pose, our regulation at 21 CFR 73.69(a)(1) requires that the aqueous extract used to produce the color additive undergo ultrafiltration. We agree with the petitioner that the totality of the evidence supports the conclusion that it is extremely unlikely that the proteins"}]}