Below are the most recent publications written about "United States Food and Drug Administration" by people in Profiles.
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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.
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Pulte ED, Chen H, Price LSL, Gudi R, Li H, Okusanya OO, Ma L, Rodriguez L, Vallejo J, Norsworthy KJ, de Claro RA, Theoret MR, Pazdur R. FDA Approval Summary: Revised Indication and Dosing Regimen for Ponatinib Based on the Results of the OPTIC Trial. Oncologist. 2022 03 04; 27(2):149-157.
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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.
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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.
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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.
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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.
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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.
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Dittmar M, Lee JS, Whig K, Segrist E, Li M, Kamalia B, Castellana L, Ayyanathan K, Cardenas-Diaz FL, Morrisey EE, Truitt R, Yang W, Jurado K, Samby K, Ramage H, Schultz DC, Cherry S. Drug repurposing screens reveal cell-type-specific entry pathways and FDA-approved drugs active against SARS-Cov-2. Cell Rep. 2021 04 06; 35(1):108959.
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Porter ED, Bessen SY, Molloy IB, Kelly JL, Ramkumar N, Phillips JD, Loehrer AP, Wilson MZ, Hasson RM, Ivatury SJ, Henkin JR, Barth RJ. Guidelines for Patient-CenteredOpioid Prescribing and Optimal FDA-Compliant Disposal of Excess Pills after Inpatient Operation: Prospective Clinical Trial. J Am Coll Surg. 2021 06; 232(6):823-835.e2.