{"source":"reg-pharma","note":"Free 5-item preview. The full feed is $0.05/call at GET /v1/reg-pharma/changes.","question":"Which final or proposed federal rules affecting prescription drugs & biologics were published since T, and which carry compliance obligations?","sample":[{"source":"reg-pharma","entityId":"fedreg:2026-10894","type":"final_rule","title":"Medical Devices; Ear, Nose, and Throat Devices; Classification of the Oropharyngeal Electrical Stimulator","summary":"The Food and Drug Administration (FDA) is classifying the oropharyngeal electrical stimulator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the oropharyngeal electrical stimulator. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing …","significance":6,"detectedAt":"2026-07-14T22:19:04.653Z","effectiveDate":"2026-06-01","sourceUrl":"https://www.federalregister.gov/documents/2026/06/01/2026-10894/medical-devices-ear-nose-and-throat-devices-classification-of-the-oropharyngeal-electrical","detail":{"documentNumber":"2026-10894","documentType":"Rule","agencies":"Health and Human Services Department, Food and Drug Administration","publicationDate":"2026-06-01","vertical":"reg-pharma"}},{"source":"reg-pharma","entityId":"fedreg:2026-10904","type":"final_rule","title":"Medical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation","summary":"The Food and Drug Administration (FDA) is classifying the orally ingested transient device for constipation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the orally ingested transient device for constipation. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative d…","significance":6,"detectedAt":"2026-07-14T22:19:04.653Z","effectiveDate":"2026-06-01","sourceUrl":"https://www.federalregister.gov/documents/2026/06/01/2026-10904/medical-devices-gastroenterology-urology-devices-classification-of-the-orally-ingested-transient","detail":{"documentNumber":"2026-10904","documentType":"Rule","agencies":"Health and Human Services Department, Food and Drug Administration","publicationDate":"2026-06-01","vertical":"reg-pharma"}},{"source":"reg-pharma","entityId":"fedreg:2026-10907","type":"final_rule","title":"Medical Devices; Anesthesiology Devices; Classification of the Real-Time Ultrasound Anatomy Visualization and Labeling Device for Ultrasound Guided Regional Anesthesia","summary":"The Food and Drug Administration (FDA) is classifying the real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and eff…","significance":6,"detectedAt":"2026-07-14T22:19:04.653Z","effectiveDate":"2026-06-01","sourceUrl":"https://www.federalregister.gov/documents/2026/06/01/2026-10907/medical-devices-anesthesiology-devices-classification-of-the-real-time-ultrasound-anatomy","detail":{"documentNumber":"2026-10907","documentType":"Rule","agencies":"Health and Human Services Department, Food and Drug Administration","publicationDate":"2026-06-01","vertical":"reg-pharma"}},{"source":"reg-pharma","entityId":"fedreg:2026-10908","type":"final_rule","title":"Medical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoring","summary":"The Food and Drug Administration (FDA) is classifying the rigid sterilization container with electronic monitoring into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the rigid sterilization container with electronic monitoring. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficia…","significance":6,"detectedAt":"2026-07-14T22:19:04.653Z","effectiveDate":"2026-06-01","sourceUrl":"https://www.federalregister.gov/documents/2026/06/01/2026-10908/medical-devices-general-hospital-and-personal-use-devices-classification-of-the-rigid-sterilization","detail":{"documentNumber":"2026-10908","documentType":"Rule","agencies":"Health and Human Services Department, Food and Drug Administration","publicationDate":"2026-06-01","vertical":"reg-pharma"}},{"source":"reg-pharma","entityId":"fedreg:2026-11104","type":"final_rule","title":"New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address; Correction","summary":"The Food and Drug Administration (FDA or we) is amending the final rule that published in the Federal Register of April 16, 2026. That final rule updated regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during October, November, and December of 2025. The final rule published with some inadvertent errors in the instructions for technical amendments. This document corrects those errors.","significance":6,"detectedAt":"2026-07-14T22:19:04.653Z","effectiveDate":"2026-06-03","sourceUrl":"https://www.federalregister.gov/documents/2026/06/03/2026-11104/new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-new-animal-drug","detail":{"documentNumber":"2026-11104","documentType":"Rule","agencies":"Health and Human Services Department, Food and Drug Administration","publicationDate":"2026-06-03","vertical":"reg-pharma"}}]}