Results 21 to 30 of about 740,134 (361)

Cardiovascular Toxicities of Ibrutinib: A Pharmacovigilance Study Based on the United States Food and Drug Administration Adverse Event Reporting System Database. [PDF]

Pharmaceuticals (Basel), 2023
Zheng Y, Guo X, Chen C, Chi L, Guo Z, Liang J, Wei L, Chen X, Ye X, He J.   +9 more
europepmc   +3 more sources

Comparison of Good Clinical Practice Inspection Processes for Marketing Applications Between the United States Food and Drug Administration and the European Medicines Agency. [PDF]

Ther Innov Regul Sci, 2023
Ayalew K, Ning YM, Foringer MJ, Leibenhaut S, Sellers JW, Yu B, Kronstein PD, Higgerson A, Mihaescu C, Rodriguez M, Williams L, Khin NA.   +11 more
europepmc   +3 more sources

Isotretinoin and Suicide: Data Mining of the United States Food and Drug Administration Adverse Event Reporting System Database. [PDF]

Cureus
Ganjikunta RK, Naik RB, Vallepalli C, M J.   +3 more
europepmc   +2 more sources

A Comparison of Pediatric and Adult Safety Studies for Antipsychotic and Antidepressant Drugs Submitted to the United States Food and Drug Administration. [PDF]

J Pediatr, 2019
Liu XI, Schuette P, Burckart GJ, Green DJ, La J, Burnham JM, Rakhmanina N, Robb A, Huang SM, van den Anker JN.   +9 more
europepmc   +2 more sources

Exploratory disproportionality analysis of potentially drug-induced eosinophilic pneumonia using United States Food and Drug Administration adverse event reporting system. [PDF]

Sci Rep
Kamath A.
europepmc   +2 more sources

A real-world study of antifibrotic drugs-related adverse events based on the United States food and drug administration adverse event reporting system and VigiAccess databases. [PDF]

Front Pharmacol
He M, Yang T, Zhou J, Wang R, Li X.
europepmc   +3 more sources

Evaluating the accuracy of Chat Generative Pre-trained Transformer version 4 (ChatGPT-4) responses to United States Food and Drug Administration (FDA) frequently asked questions about dental amalgam. [PDF]

BMC Oral Health
Buldur M, Sezer B.
europepmc   +3 more sources

Role of the U.S. Food and Drug Administration in the Regulatory Management of Human Listeriosis in the United States

Journal of Food Protection, 2008
From 1986 to 2006, the incidence of listeriosis in the United States dropped from approximately seven to three cases per million population, a reduction that most likely reflects the joint efforts of industry, government, consumers, and academia. Herein, we describe the U.S.
David W. K. Acheson, Judy O. Lee, Karl C. Klontz, Atin R. Datta, Patrick V. McCarthy, Robert E. Brackett   +5 more
openaire   +4 more sources

Comparing Generic and Innovator Drugs: A Review of 12 Years of Bioequivalence Data from the United States Food and Drug Administration [PDF]

The Annals of Pharmacotherapy, 2009
Barbara M. Davit, Patrick E. Nwakama, Gary Buehler, Dale P. Conner, Sam Haidar, Dewrat T Patel, Yongsheng Yang, Lawrence X. Yu, Janet Woodcock   +8 more
openalex   +2 more sources

United States Food and Drug Administration TASS Program [PDF]

Ophthalmology, 2013
Nick Mamalis
openaire   +4 more sources