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"document_number": "2026-03094",
"title": "Agency Information Collection Activities; Proposed Collection; Comment Request; Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions",
"type": "Notice",
"abstract": "The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection relating to our Patent Term Restoration regulations.",
"action": "Notice.",
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"document_number": "2026-03311",
"title": "Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe Processing and Importing of Fish and Fishery Products",
"type": "Notice",
"abstract": "The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with safe and sanitary processing and importing of fish and fishery products.",
"action": "Notice.",
"html_url": "https://www.federalregister.gov/documents/2026/02/19/2026-03311/agency-information-collection-activities-proposed-collection-comment-request-procedures-for-the-safe",
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"document_number": "2026-03312",
"title": "Determination of Regulatory Review Period for Purposes of Patent Extension; SYMVESS",
"type": "Notice",
"abstract": "The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SYMVESS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.",
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"title": "Patent Term Application for SYMVESS (acellular tissue engineered vessel-tyod), Patent No. 9,657,265",
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"dates": "Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic or written comments and ask for a redetermination by April 20, 2026. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 18, 2026. See \"Petitions\" in the SUPPLEMENTARY INFORMATION section for more information.",
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{
"document_number": "2026-03326",
"title": "Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients) and the Advanced Manufacturing Technologies Designation Program",
"type": "Notice",
"abstract": "The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with CGMP for drugs, finished pharmaceuticals, including active pharmaceutical ingredients (APIs), and the advanced manufacturing technologies (AMT) designation program.",
"action": "Notice.",
"html_url": "https://www.federalregister.gov/documents/2026/02/20/2026-03326/agency-information-collection-activities-proposed-collection-comment-request-current-good",
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"comments_close_on": "2026-04-21",
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"title": "Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients) and the Advanced Manufacturing Technologies Designation Program",
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"document_number": "2026-03332",
"title": "Agency Information Collection Activities; Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice",
"type": "Notice",
"abstract": "The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection provisions of our regulations mandating the application of hazard analysis and critical control point (HACCP) principles to the processing of fruit and vegetable juices.",
"action": "Notice.",
"html_url": "https://www.federalregister.gov/documents/2026/02/20/2026-03332/agency-information-collection-activities-proposed-collection-comment-request-hazard-analysis-and",
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"comments_close_on": "2026-04-21",
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"document_number": "2026-03333",
"title": "Agency Information Collection Activities; Proposed Collection; Comment Request; Approved Organizations for Wholesale Drug Distributors and Third-Party Logistics Providers",
"type": "Notice",
"abstract": "The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on approved organizations involved in the licensure and inspection process for wholesale drug distributors (\"wholesale distributors\") and third-party logistics providers (\"3PLs\"), as directed by the Drug Supply Chain Security Act (DSCSA).",
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{
"document_number": "2026-03352",
"title": "Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Events Associated With New Animal Drugs",
"type": "Notice",
"abstract": "The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on adverse event reporting by FDA on new animal drugs and product manufacturing defects.",
"action": "Notice.",
"html_url": "https://www.federalregister.gov/documents/2026/02/20/2026-03352/agency-information-collection-activities-proposed-collection-comment-request-adverse-events",
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"document_number": "2026-03353",
"title": "Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Minor Use and Minor Species",
"type": "Notice",
"abstract": "The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with designation of new animal drugs for minor use and minor species and indexing of new animal drugs for minor species.",
"action": "Notice.",
"html_url": "https://www.federalregister.gov/documents/2026/02/20/2026-03353/agency-information-collection-activities-proposed-collection-comment-request-new-animal-drugs-for",
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{
"document_number": "2026-05259",
"title": "Labeling and Preventing Cross-Contact of Gluten for Packaged Foods; Request for Information; Extension of Comment Period",
"type": "Notice",
"abstract": "The Food and Drug Administration (FDA or we) is extending the comment period for the notice that appeared in the Federal Register on January 22, 2026. In the notice, FDA requested data and information on the issues raised in and specific questions related to a citizen petition from Celiac Journey related to labeling and preventing cross- contact of gluten for packaged foods. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.",
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"title": "Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications-Considerations Related to Youth Risk; Draft Guidance for Industry; Availability",
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"document_number": "2026-15429",
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"document_number": "2026-05280",
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"document_number": "2026-05320",
"title": "Medical Devices; Radiology Devices; Classification of Blood Irradiators",
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"abstract": "The Food and Drug Administration (FDA) is proposing to classify blood irradiator devices (product code MOT), unclassified preamendments devices, as follows: blood irradiator devices intended to prevent transfusion-associated graft-versus-host disease into class II (special controls) with premarket notification and blood irradiator devices intended to prevent metastasis into class III (premarket approval) to provide a reasonable assurance of safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is issuing a proposed order proposing to require the filing of a premarket approval application for blood irradiator devices intended to prevent metastasis.",
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"title": "Reference 12 - X\u2010ray irradiation effectively inactivated lymphocytes in transfusion in vivo monitored by the bioluminescence transfusion-associated graft-versus-host disease model",
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"title": "Reference 9 - Transfusion-associated graft-versus-host disease transfusion-associated hyperkalemia, and potassium filtration: advancing safety and sufficiency of the blood supply",
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"title": "Reference 7 - Influence of Irradiation on Leukodepleted Small Unit Red Blood Cell Bags",
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"title": "Reference 6 - Serial assessment of biochemical changes in irradiated red blood cells",
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"document_number": "2026-05322",
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"dates": "Either electronic or written comments on the proposed order must be submitted by May 18, 2026. FDA intends that, if a final order based on this proposed order is issued, anyone who wishes to market blood irradiators intended for use in the irradiation of intraoperatively salvaged blood for cancer patients undergoing surgery to assist in the prevention of metastasis must submit a PMA prior to the last day of the 30th calendar month beginning after the month in which the classification of the device in class III became effective. See section III for the effective date of any final order that may publish based on this proposed order. See section VI of this document for more information about submitting a PMA.",
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"document_number": "2026-05329",
"title": "Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notifications Submission",
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"abstract": "The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the applicable regulations, and the guidance documents and agency forms related to Premarket Notifications of Devices.",
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"title": "General Considerations for the Use of New Approach Methodologies in Drug Development; Draft Guidance for Industry; Availability",
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"abstract": "The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \"General Considerations for the Use of New Approach Methodologies in Drug Development.\" The purpose of this draft guidance is to provide drug developers with a validation framework and general recommendations for using new approach methodologies (NAMs) in drug development. Although animal toxicity studies have proved to be a critical method to identify potential risks to human health, finding ways to improve human relevance while reducing the use of animals by developing reliable NAMs furthers an important Center for Drug Evaluation and Research (CDER) priority to move away from reliance on animal testing. The recommendations in this draft guidance are intended to highlight scientific principles of study design and reporting that can be applied broadly and flexibly in the validation of NAMs used in drug development. This draft guidance is not intended to address specific NAMs and does not address the use of NAMs in drug discovery; rather, it encourages the use of NAMs in regulatory submissions, especially when they improve the predictivity of nonclinical studies for increased safety in clinical trials.",
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"abstract": "The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry entitled \"Questions and Answers About Requirements for Additional Traceability Records for Certain Foods.\" The draft guidance answers questions about the final rule entitled \"Requirements for Additional Traceability Records for Certain Foods,\" which established additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List. The draft guidance is intended to answer questions to facilitate industry's understanding of the final rule.",
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"document_number": "2026-05620",
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"title": "Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests",
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"title": "Reference 1 - P010033 Approval Order",
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"document_number": "2026-08281",
"title": "AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information",
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"abstract": "The Food and Drug Administration (FDA or the Agency) is issuing this request for information to solicit input on a proposed pilot program to assess how artificial intelligence (AI)-enabled technologies can improve efficiency, speed, and quality of decision- making in early phase clinical trials. Early-phase clinical trials represent a critical bottleneck in drug development, often characterized by high uncertainty, limited patient populations, and inefficient decision- making processes. This pilot program aims to explore how advances in AI and data science can improve trial efficiency, enhance safety monitoring, facilitate dose selection decisions, and enable more informed early go/no-go decisions (e.g., a regulatory decision as to whether a Phase 1 study may proceed) while maintaining FDA's rigorous scientific and regulatory standards and promoting trustworthy AI systems. The pilot program will be guided by principles aligned with the National Institute of Standards and Technology (NIST) AI Risk Management Framework (AI RMF).",
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{
"document_number": "2026-04196",
"title": "Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments",
"type": "Notice",
"abstract": "The Food and Drug Administration (FDA, the Agency, or we) is announcing the opening of a public docket to solicit information and comments on the Agency's series of guidances for industry on scale-up and postapproval changes (SUPAC) for specific dosage forms. Specifically, we are seeking comment on the following guidances for industry: \"Immediate Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation\" (SUPAC- IR); \"SUPAC-IR Questions and Answers about SUPAC-IR Guidance\" (SUPAC- IR Q&A); \"Nonsterile Semisolid Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation\" (SUPAC-SS); \"SUPAC- MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation\" (SUPAC-MR); and \"SUPAC: Manufacturing Equipment Addendum\" (SUPAC-MEA). The Agency is seeking public information and comment on the continued utility of and suggestions for potential revisions to the recommendations in these guidances.",
"action": "Notice; request for information and comments.",
"html_url": "https://www.federalregister.gov/documents/2026/03/03/2026-04196/recommendations-on-scale-up-and-postapproval-changes-guidances-for-industry-request-for-comments",
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"document_number": "2026-06184",
"title": "Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products; Request for Information and Comments",
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"abstract": "Digital health technologies (DHTs) used for remote data acquisition are playing a growing role in health care and offer important opportunities in clinical research. As outlined in the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA VII) included as part of the FDA User Fee Reauthorization Act of 2022, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have committed to supporting the use of DHTs in drug and biological product development. To inform potential FDA activities in this area, CDER and CBER are requesting information to better understand the opportunities and challenges sponsors and other interested parties face in making innovative use of DHTs in clinical investigations of drugs and biological products.",
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"title": "Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs",
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"action": "Notice of availability.",
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"document_number": "2026-07629",
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"abstract": "The Food and Drug Administration (FDA, the Agency, or we) is establishing a public docket to collect examples about how previous patient-focused drug development (PFDD) meetings have impacted stakeholders' drug development efforts. This includes impacts on community engagement, research priorities, advocacy strategies, medical product development programs, clinical practice, and other areas of interest.",
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"title": "List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act",
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"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.",
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"title": "Agency Information Collection Activities; Proposed Collection; Comment Request; National Youth Tobacco Survey",
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"abstract": "The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the National Youth Tobacco Survey.",
"action": "Notice.",
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"document_number": "2026-12621",
"title": "Expedited Investigational New Drug Pilot Program; Request for Information",
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"document_number": "2026-07248",
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"document_number": "2026-12579",
"title": "Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification of Identity, Form FDA 3975",
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"abstract": "The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.",
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"document_number": "2026-12619",
"title": "Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials; Draft Guidance for Industry; Availability",
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"document_number": "2026-10372",
"title": "Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act",
"type": "Notice",
"abstract": "The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection relating to human drug compounding.",
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"document_number": "2026-12620",
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"document_number": "2026-14672",
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"action": "Notice; request for information; establishment of a public docket; extension of the comment period.",
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"document_number": "2026-14909",
"title": "Proposal To Revoke the Color Additive Listing for Use of Citrus Red No. 2 on the Skins of Mature Oranges",
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"abstract": "The Food and Drug Administration (FDA or we) is proposing to issue an order that would repeal the color additive regulation that allows for the use of Citrus Red No. 2 for coloring the skins of mature oranges. Based on certification data, it appears that Citrus Red No. 2 is no longer used for coloring the skins of oranges and has not been certified for use as a color additive in food marketed in the United States since 2020. Because the authorized use of Citrus Red No. 2 appears to have been abandoned, we have tentatively concluded that this color additive regulation is outdated and unnecessary.",
"action": "Proposed amendment; proposed order.",
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"document_number": "2026-17229",
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"abstract": "The Food and Drug Administration (FDA or the Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled \"Modifications to the List of Recognized Standards, Recognition List Number: 066\" (Recognition List Number: 066), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.",
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{
"document_number": "2026-12884",
"title": "Agency Information Collection Activities; Proposed Collection; Comment Request; Time and Extent Applications for Nonprescription Drug Products",
"type": "Notice",
"abstract": "The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on time and extent applications for nonprescription drug products.",
"action": "Notice.",
"html_url": "https://www.federalregister.gov/documents/2026/06/26/2026-12884/agency-information-collection-activities-proposed-collection-comment-request-time-and-extent",
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"title": "Meetings: Patient-Focused Drug Development for Long COVID",
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{
"document_number": "2026-15070",
"title": "Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees",
"type": "Notice",
"abstract": "The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.",
"action": "Notice.",
"html_url": "https://www.federalregister.gov/documents/2026/07/27/2026-15070/agency-information-collection-activities-submission-for-office-of-management-and-budget-review",
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"dates": "Submit written comments (including recommendations) on the collection of information by August 26, 2026.",
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{
"document_number": "2026-11054",
"title": "Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry; Availability",
"type": "Notice",
"abstract": "The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled \"Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing.\" The draft guidance document provides sponsors engaged in the development of human gene therapy (GT) products incorporating ex-vivo and in vivo genome editing (GE) of human somatic cells (GE products) with FDA's recommendations on the type of prior knowledge that may be scientifically appropriate to leverage to advance product development.",
"action": "Notice of availability.",
"html_url": "https://www.federalregister.gov/documents/2026/06/03/2026-11054/leveraging-prior-knowledge-in-the-development-of-human-gene-therapy-products-incorporating-genome",
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"publication_date": "2026-06-03",
"comments_close_on": "2026-09-01",
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{
"document_number": "2026-17380",
"title": "International Drug Scheduling; Single Convention on Narcotic Drugs; Convention on Psychotropic Substances; Clobromazolam (Phenazolam); Cychlorphine (N-Propionitrile Chlorphine); Desalkylgidazepam (Bromonordiazepam); Ethylbromazolam; Etomethazene (5-Methyl Etodesnitazene); Spirochlorphine (R6980); Etomidate; Medetomidine; Request for Comments",
"type": "Notice",
"abstract": "The Food and Drug Administration (FDA or Agency) is providing interested persons with the opportunity to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of eight drug substances. These comments will be considered in preparing a response from the United States to the Expert Committee on Drug Dependence (ECDD) regarding the abuse liability and diversion of these drugs. The ECDD will use this information to consider whether to recommend that certain international restrictions be placed on these drug substances. This notice requesting comments is required by the Controlled Substances Act (CSA).",
"action": "Notice; request for comments.",
"html_url": "https://www.federalregister.gov/documents/2026/08/26/2026-17380/international-drug-scheduling-single-convention-on-narcotic-drugs-convention-on-psychotropic",
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"publication_date": "2026-08-26",
"comments_close_on": "2026-09-03",
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"document_number": "2026-16943",
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"document_number": "2026-15285",
"title": "Product-Specific Guidances; Revised Draft Guidances for Industry; Availability",
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"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.",
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"title": "PSG_212477 - Draft Guidance on Ledipasvir; Sofosbuvir re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability",
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"title": "PSG_208612 - Draft Guidance on Ethinyl Estradiol; Levonorgestrel re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability",
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"title": "PSG_206089 - Draft Guidance on Testosterone Undecanoate re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability",
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"title": "PSG_212862 - Draft Guidance on Pretomanid",
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"title": "PSG_208910 - Draft Guidance on Vancomycin Hydrochloride",
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"document_number": "2026-17601",
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"document_number": "2026-17677",
"title": "Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product Violations Reporting Form",
"type": "Notice",
"abstract": "The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.",
"action": "Notice.",
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"document_number": "2026-06660",
"title": "Electronic Submission of Postmarketing Individual Case Safety Reports to the Food and Drug Administration Adverse Event Monitoring System Using International Council of Harmonisation E2B(R3) Data Standards; Regional Data Elements and Implementation Schedule",
"type": "Notice",
"abstract": "The Food and Drug Administration (FDA or we) is announcing an updated data standard requirement for the submission of postmarketing individual case safety report (ICSR) submissions for human drug products, biological products, and drug- or biologic-led combination products to the FDA Adverse Event Monitoring System (AEMS) database (formerly FDA Adverse Event Reporting System (FAERS)) via the Electronic Submissions Gateway Next Generation (ESG NextGen). Starting October 1, 2026, postmarketing ICSRs must be reported using the data standards adopted by FDA in the International Council for Harmonisation (ICH) guidance for industry entitled \"E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide--Data Elements and Message Specification\" (ICH E2B(R3) Implementation Guidance), which incorporates by reference regional implementation guides (collectively ICH E2B(R3) data standards).",
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"document_number": "2026-15339",
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"abstract": "The Food and Drug Administration (FDA, the Agency, or we) is announcing the fee rates and payment procedures for fiscal year (FY) 2027 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Drug User Fee Amendments of 2023 (ADUFA V), authorizes FDA to collect user fees for certain animal drug applications and supplemental animal drug applications, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2027.",
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"document_number": "2026-15341",
"title": "Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2027",
"type": "Notice",
"abstract": "The Food and Drug Administration (FDA, the Agency, or we) is announcing the fee rates and payment procedures for fiscal year (FY) 2027 generic new animal drug program user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2023 (AGDUFA IV), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs (JINADs), and for certain submissions related to JINAD files. This notice establishes the fee rates for FY 2027.",
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{
"document_number": "2026-15612",
"title": "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability",
"type": "Notice",
"abstract": "The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry titled \"Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs.\" This revised draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation (and sensitization, if applicable) potential of a proposed transdermal or topical delivery system (collectively referred to as TDS). The recommendations in this revised draft guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The revised draft guidance is intended to clarify FDA's recommendations and expectations related to in vivo skin irritation and in vivo combined skin irritation and sensitization studies. This draft guidance replaces the draft guidance \"Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs\" (April 2023).",
"action": "Notice of availability.",
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"title": "Reference 7 - Corpas, E., et al. \u2018\u2018Vitamin D and Calcium Deficiency in the Elderly.\u2019\u2019 Endocrinology of Aging: Clinical Aspects in Diagrams and Images, edited by E. Corpas et al., Academic Press, 2021, pp. 103\u2013130, https://doi.org/10.1016/B978-0-12-819667-0.00004-4.",
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"title": "Guidance Reference 5 - Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products Draft Guidance for Industry",
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"title": "Guidance Reference 4 - Q5E Comparability of Biotechnological Biological Products Subject to Changes in Their Manufacturing Process Guidance for Industry",
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"document_number": "2026-19281",
"title": "Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002",
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"abstract": "The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.",
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"document_number": "2026-19282",
"title": "Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption",
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"abstract": "The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of our reporting requirements contained in FDA regulations governing state petitions for exemption from preemption.",
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"document_number": "2026-19283",
"title": "Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications",
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"abstract": "The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting requirements contained in existing FDA regulations governing temporary marketing permit applications.",
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"document_number": "2026-20427",
"title": "Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information",
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"abstract": "The Food and Drug Administration (FDA or the Agency) is describing the approaches it is considering for the design of early- phase clinical trials of ibogaine drug products and is opening a public docket to receive comments. The Department of Health and Human Services (HHS) is funding clinical development of ibogaine, and the first federally supported trials are expected to study ibogaine in adults with opioid use disorder (OUD) and adults with post-traumatic stress disorder (PTSD). FDA is building on the guidance for industry entitled \"Psychedelic Drugs: Considerations for Clinical Investigations\" by seeking comments, data, and information from the public on protocol elements relevant to ibogaine development--including dose selection and escalation, care setting, safety monitoring, eligibility criteria, stopping rules, and safety oversight, in part, because the Federal Government is funding work in this area. FDA will consider all information provided in response to this Request for Information (RFI) to inform whether and how these specific elements should be considered in its review of Investigational New Drug Applications (INDs) involving ibogaine.",
"action": "Notice; request for information; establishment of a public docket.",
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"publication_date": "2026-10-06",
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"title": "Reference 6. - Ona, G., Rocha, J.M., Bouso, J.C., Hallak, J.E.C., Borra`s, T., et al., \u2018\u2018The adverse events of ibogaine in humans: an updated systematic review of the literature (2015\u20132020),\u2019\u2019 Psychopharmacology, 239(6):1977\u20131987\n(2022), available at doi:10.1007/s00213-021-05964-y.",
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"title": "Reference 5 - Kock, P., Froelich, K., Walter, M., Lang, U., and K.M. Du\u00a8 rsteler, \u2018\u2018A systematic literature review of clinical trials and therapeutic applications of ibogaine,\u2019\u2019 J. Subst. Abuse Treat., 138:108717 (2022), available at doi:10.1016/j.jsat.2021.108717.",
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"title": "Reference 4 - Knuijver, T., ter Heine, R., Schellekens, A.F.A., Heydari, P., Lucas, L., et al., \u2018\u2018The pharmacokinetics and pharmacodynamics of ibogaine in opioid use disorder patients,\u2019\u2019 J. Psychopharmacol., 38(5):481\u2013488 (2024),\navailable at doi:10.1177/02698811241237873.",
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"title": "Reference 3 - Knuijver, T., Schellekens, A., Belgers, M., Donders, R., van Oosteren, T., et al., \u2018\u2018Safety of ibogaine administration in detoxification of opioid-dependent individuals: a descriptive open-label observational study,\u2019\u2019 Addiction, 117(1):118\u2013128 (2022), available at doi:10.1111/add.15448.",
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"title": "Reference 2 - Brunt, T.M., \u2018\u2018Rare but relevant: ibogaine and cardiovascular complications\u2014 prolonged QT interval and ventricular arrhythmias,\u2019\u2019 Addiction, 121(6):1616\u2013 1621 (2026), available at doi:10.1111/add.70319.",
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"title": "Reference 1 - Alper, K.R., Stajic\u00b4, M., and J.R. Gill, \u2018\u2018Fatalities temporally associated with the ingestion of ibogaine,\u2019\u2019 J. Forensic Sci., 57(2):398\u2013412 (2012), available at doi:10.1111/j.1556-4029.2011.02008.x.",
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"document_number": "2026-20721",
"title": "Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Draft Guidance for Industry; Availability",
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"document_number": "2026-19704",
"title": "Robotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability",
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"title": "Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage; Draft Guidance for Industry; Availability",
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"document_number": "2026-19349",
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"document_number": "2025-00830",
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