{"description":"Documents matching 'artificial intelligence', published on or after 04/01/2026, and from Food and Drug Administration","count":4,"total_pages":1,"results":[{"title":"AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information","type":"Notice","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).","document_number":"2026-08281","html_url":"https://www.federalregister.gov/documents/2026/04/29/2026-08281/ai-enabled-optimization-of-early-phase-clinical-trials-pilot-program-request-for-information","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-29/pdf/2026-08281.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08281.pdf?1777389315","publication_date":"2026-04-29","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":"cited in FDA's Draft Guidance for Industry on Considerations for the Use of AI to Support Regulatory Decision-Making for Drugs and Biological Products):\n \n The term “<span class=\"match\">artificial</span> <span class=\"match\">intelligence</span>” means a machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments. <span class=\"match\">Artificial</span> <span class=\"match\">intelligence</span> systems use machine and human-based inputs to— \n (A) perceive real and virtual environments; \n (B) abstract such perceptions into models through analysis in an automated"},{"title":"AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information; Extension of Comment Period","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled \"AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information\" that appeared in the Federal Register of April 29, 2026. In the notice, FDA requested comments 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. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.","document_number":"2026-10602","html_url":"https://www.federalregister.gov/documents/2026/05/28/2026-10602/ai-enabled-optimization-of-early-phase-clinical-trials-pilot-program-request-for-information","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-28/pdf/2026-10602.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10602.pdf?1779885915","publication_date":"2026-05-28","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":"entitled “AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information” that appeared in the \n Federal Register \n of April 29, 2026. In the notice, FDA requested comments to solicit input on a proposed pilot program to assess how <span class=\"match\">artificial</span> <span class=\"match\">intelligence</span> (AI)-enabled technologies can improve efficiency, speed, and quality of decision-making in early phase clinical trials. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.\n \n \n"},{"title":"Drug Repurposing for Unmet Medical Needs; Request for Information","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is opening a public docket to solicit input and comments on FDA's efforts with respect to drug repurposing to address unmet medical needs. FDA is requesting information on potential priority disease areas and potential candidates for drug repurposing, with a focus on FDA-approved drugs for which there appears to be no commercial interest in adding a new use through a supplement to a new drug application (supplemental application). Information provided through this public docket will help the Agency refine our efforts toward considering and evaluating candidates for drug repurposing.","document_number":"2026-09366","html_url":"https://www.federalregister.gov/documents/2026/05/12/2026-09366/drug-repurposing-for-unmet-medical-needs-request-for-information","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-12/pdf/2026-09366.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-09366.pdf?1778503530","publication_date":"2026-05-12","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":"effectiveness for a new use.\n \n \n There may also be situations in which there is information that suggests the potential for a clinical benefit of a drug to treat a disease or condition based on pre-clinical data—\n e.g., \n via high-throughput screening, in vitro models, or <span class=\"match\">artificial</span> <span class=\"match\">intelligence</span>/machine learning—but for which there is currently no clinical evidence. Please submit ideas for candidates that meet these criteria, as well as an overview of the existing data which you believe is promising enough to merit further study.\n \n \n 3. \n Approaches to identifying"},{"title":"Statement of Organization, Functions, and Delegations of Authority","type":"Notice","abstract":"The Food and Drug Administration's (FDA) plans to centralize and enhance key functions across the agency. These changes will reduce redundancies, improve efficiency, and advance alignment to better serve the American public.","document_number":"2026-15297","html_url":"https://www.federalregister.gov/documents/2026/07/29/2026-15297/statement-of-organization-functions-and-delegations-of-authority","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-29/pdf/2026-15297.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-15297.pdf?1785251709","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":"DIVISION OF MEDICAL POLICY DEVELOPMENT (DCDHCA) \n DIVISION OF MEDICAL POLICY PROGRAMS (DCDHCB) \n OFFICE OF INNOVATION AND CLINICAL TRIAL MODERNIZATION (DCDHD) \n CLINICAL METHODOLOGY STAFF (DCDHD1) \n DIVISION OF REAL-WORLD EVIDENCE ANALYTICS (DCDHDA) \n DIVISION OF <span class=\"match\">ARTIFICIAL</span> <span class=\"match\">INTELLIGENCE</span> (DCDHDB) \n OFFICE OF TRANSLATIONAL SCIENCES (DCDJ) \n OFFICE OF BIOSTATISTICS (DCDJA) \n PROJECT MANAGEMENT STAFF (DCDJA2) \n DIVISION OF BIOMETRICS I (DCDJAA) \n DIVISION OF BIOMETRICS II (DCDJAB) \n DIVISION OF BIOMETRICS III (DCDJAC) \n DIVISION OF BIOMETRICS IV (DCDJAD)"}]}