Below are the most recent publications written about "United States Food and Drug Administration" by people in Profiles.
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de Leon J, Baldessarini RJ, Balon R, Bilbily J, Caroff SN, Citrome L, Correll CU, Cotes RO, Davis JM, DeLisi LE, Faden J, Freudenreich O, Goldsmith DR, Gurrera R, Josiassen RC, Kane JM, Kelly DL, Keshavan MS, Laitman RS, Lam YWF, Leung JG, Love RC, McCollum B, McGrane IR, Meyer JM, Nasrallah HA, Nucifora FC, Rothschild AJ, Rubio JM, Sajatovic M, Sarpal DK, Schoretsanitis G, Shad M, Shelton C, Sher L, Singh B, Surya S, Zarzar TR, Sanz EJ, De Las Cuevas C. Letter to the FDA Proposing Major Changes in the US Clozapine Package Insert Supported by Clozapine Experts Worldwide. Part II: A Review of Fatal Outcomes in US Pharmacovigilance Data and Proposed Changes. J Clin Psychopharmacol. 2025 May-Jun 01; 45(3):197-218.
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de Leon J, Baldessarini RJ, Balon R, Bilbily J, Caroff SN, Citrome L, Correll CU, Cotes RO, Davis JM, DeLisi LE, Faden J, Freudenreich O, Goldsmith DR, Gurrera R, Josiassen RC, Kane JM, Kelly DL, Keshavan MS, Laitman RS, Lam YWF, Leung JG, Love RC, McCollum B, McGrane IR, Meyer J, Nasrallah HA, Nucifora FC, Rothschild AJ, Rubio JM, Sajatovic M, Sarpal DK, Schoretsanitis G, Shad M, Shelton C, Sher L, Singh B, Surya S, Zarzar TR, Sanz EJ, De Las Cuevas C. Letter to the FDA Proposing Major Changes in the US Clozapine Package Insert Supported by Clozapine Experts Worldwide. Part I: A Review of the Pharmacokinetic Literature and Proposed Changes. J Clin Psychopharmacol. 2025 May-Jun 01; 45(3):179-196.
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Yukselen Z, Raju AKV, Kumar PA, Ujjawal A, Dasari M, Parajuli S, Nakhla M, Bansal K, Ganatra S, Dani SS. A Real-World Pharmacovigilance Study of FDA Adverse Event Reporting System (FAERS) for Mavacamten. Am J Cardiovasc Drugs. 2024 Nov; 24(6):791-799.
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Kay J, Nikolov NP, Weisman MH. American College of Rheumatology and Food and Drug Administration Summit: Summary of the Meeting, May 17-18, 2022. Arthritis Rheumatol. 2024 Sep; 76(9):1323-1333.
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Vishakha S, Navneesh N, Kurmi BD, Gupta GD, Verma SK, Jain A, Patel P. An Expedition on Synthetic Methodology of FDA-approved Anticancer Drugs (2018-2021). Anticancer Agents Med Chem. 2024; 24(8):590-626.
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Vandenberg LN, Zoeller RT, Prins GS, Trasande L. Evaluating adverse effects of environmental agents in food: a brief critique of the US FDA's criteria. Environ Health. 2023 04 21; 22(1):38.
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Donovan SM, Abrams SA, Azad MB, Belfort MB, Bode L, Carlson SE, Dallas DC, Hettinga K, J?rvinen K, Kim JH, Lebrilla CB, McGuire MK, Sela DA, Neu J. Summary of the Joint National Institutes of Health and the Food and Drug Administration Workshop Titled "Exploring the Science Surrounding the Safe Use of Bioactive Ingredients in Infant Formula: Considerations for an Assessment Framework". J Pediatr. 2023 04; 255:30-41.e1.
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Davidson BL, Gao G, Berry-Kravis E, Bradbury AM, B?nnemann C, Buxbaum JD, Corcoran GR, Gray SJ, Gray-Edwards H, Kleiman RJ, Shaywitz AJ, Wang D, Zoghbi HY, Flotte TR, Tauscher-Wisniewski S, Tifft CJ, Sahin M. Gene-based therapeutics for rare genetic neurodevelopmental psychiatric disorders. Mol Ther. 2022 07 06; 30(7):2416-2428.
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Ebrahimian S, Kalra MK, Agarwal S, Bizzo BC, Elkholy M, Wald C, Allen B, Dreyer KJ. FDA-regulated AI Algorithms: Trends, Strengths, and Gaps of Validation Studies. Acad Radiol. 2022 04; 29(4):559-566.
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Batra A, Patel B, Addison D, Baldassarre LA, Desai N, Weintraub N, Deswal A, Hussain Z, Brown SA, Ganatra S, Agarwala V, Parikh PM, Fradley M, Ghosh A, Guha A. Cardiovascular safety profile of taxanes and vinca alkaloids: 30 years FDA registry experience. Open Heart. 2021 12; 8(2).