Below are the most recent publications written about "United States Food and Drug Administration" by people in Profiles.
-
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.
-
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.
-
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.
-
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.
-
Tong JY, Pasick LJ, Benito DA, Monfared A, Sataloff RT. Adverse Events Associated With Ossicular Prostheses: Utility of a Federal Database. Otol Neurotol. 2022 02 01; 43(2):e229-e234.
-
Sedhom R, Abdelmaseeh P, Haroun M, Megaly M, Narayanan MA, Syed M, Ambrosia AM, Kalra S, George JC, Jaber WA. Complications of Penumbra Indigo Aspiration Device in Pulmonary Embolism: Insights From MAUDE Database. Cardiovasc Revasc Med. 2022 06; 39:97-100.
-
Samdani AF, Pahys JM, Ames RJ, Grewal H, Pelletier GJ, Hwang SW, Betz RR. Prospective Follow-up Report on Anterior Vertebral Body Tethering for Idiopathic Scoliosis: Interim Results from an FDA IDE Study. J Bone Joint Surg Am. 2021 09 01; 103(17):1611-1619.
-
Khin NA, Grandinetti C, Dixey H, Yu B, Skeete R, Ayalew K, Budwal-Jagait M, Cho SJ, Dasgupta A, Fisher A, Kleppinger C, Kronstein PD, Martin J, McGuinness M, Mulinde J, Vinter S, Wakelin-Smith J, Walker P, Francis G. Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK. Clin Pharmacol Ther. 2022 07; 112(1):31-43.
-
Woronik A, Shaffer HW, Kiontke K, Laurent JM, Zambrano R, Daley M, Boeke JD, Fitch DHA. EUAdb: A resource for COVID-19 test development and comparison. PLoS One. 2021; 16(8):e0255417.
-
Goh GS, Tornetta P, Parvizi J. Facilitating the Approval Process of Anti-Infective Technologies and Advancing Them to the Market: Insights from an FDA Workshop on Orthopaedic Device-Related Infections. J Bone Joint Surg Am. 2021 08 04; 103(15):e57.