Below are the most recent publications written about "United States Food and Drug Administration" by people in Profiles.
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Larson AN, Todderud JE, Mathew SE, Nassr A, Sebastian AS, Potter DD, Milbrandt TA. Vertebral Body Tethering in Skeletally Immature Patients: Results of a Prospective U.S. FDA Investigational Device Exemption Study. J Bone Joint Surg Am. 2025 Feb 05; 107(3):249-256.
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Hunter AM, Patnaik MM, Itzykson R, Mesa R, Karanes C, Li Y, de Claro RA, Norsworthy KJ, Theoret M, Pulte E, Padron E. Perspectives on drug development in chronic myelomonocytic leukemia: changing the paradigm. Blood. 2024 Nov 07; 144(19):1987-1992.
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Javidnia M, Irier HA, Kassim S, Cho SJ. Remote Regulatory Assessments of Bioavailability/Bioequivalence Study Conduct by the Office of Study Integrity and Surveillance. AAPS PharmSciTech. 2024 Oct 10; 25(7):240.
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Harris L, Shankar LK, Hildebrandt C, Rubinstein WS, Langlais K, Rodriguez H, Berger A, Freymann J, Huang EP, Williams PM, Zenklusen JC, Ochs R, Tezak Z, Sahiner B. Resource requirements to accelerate clinical applications of next-generation sequencing and radiomics: workshop commentary and review. J Natl Cancer Inst. 2024 10 01; 116(10):1562-1570.
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Talasila S, Lee E, Teichner EM, Siegfried EC, Jackson Cullison SR. Analysis of publicly available adverse events reported for pediatric patients treated with Janus kinase inhibitors. Pediatr Dermatol. 2024 Nov-Dec; 41(6):1040-1046.
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Kalavar M, Lovett EA, Nicholas MP, Ross-Hirsch A, Nirwan RS, Sridhar J, Patel S, Flynn HW, Albini TA, Kuriyan AE. Update on "Cell Therapy" Clinics Offering Treatments of Ocular Conditions Using Direct-To-Consumer Marketing Websites in the U.S. Am J Ophthalmol. 2024 Nov; 267:135-141.
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Gardner RA, White C, Elsallab M, Farnia S, Fraint E, Grilley B, Bateman-House A, Grupp SA, Kenderian S, Locke FL, Nikiforow S, Oluwole OO, Rouce RH, Spiegel J, Shah NN, Sharma A, Komanduri K, Gill S. ACT To Sustain: Adoptive Cell Therapy To Sustain Access to Non-Commercialized Genetically Modified Cell Therapies. Transplant Cell Ther. 2024 08; 30(8):776-787.
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Yasinskaya Y, Bala S, Waack U, Dixon C, Higgins K, Moore JN, Jjingo CJ, O'Shaughnessy E, Colangelo P, Botgros R, Nambiar S, Angulo D, Dane A, Chiller T, Hodges MR, Sandison T, Hope W, Walsh TJ, Pappas P, Katragkou A, Kovanda L, Rex JH, Marr KA, Ostrosky-Zeichner L, Sekine S, Deshpande M, Shukla SJ, Farley J. Food and Drug Administration Public Workshop Summary-Development Considerations of Antifungal Drugs to Address Unmet Medical Need. Clin Infect Dis. 2023 08 14; 77(3):380-387.
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Issa TZ, Lambrechts MJ, Lin JS, Brush PL, Canseco JA, Hilibrand AS, Kepler CK, Schroeder GD, Vaccaro AR. Diversity in Orthopaedic Surgery Medical Device Clinical Trials: An Analysis of the Food and Drug Administration Safety and Innovation Act. J Am Acad Orthop Surg. 2023 Feb 01; 31(3):155-165.
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Potnis KC, Ross JS, Aneja S, Gross CP, Richman IB. Artificial Intelligence in Breast Cancer Screening: Evaluation of FDA Device Regulation and Future Recommendations. JAMA Intern Med. 2022 12 01; 182(12):1306-1312.