Works matching United States. Food %26 Drug Administration

Results: 5000

Brief report on the United States Food and Drug Administration Blood Products Advisory Committee recommendations for management of donors and units testing positive for hepatitis B virus DNA.

Published in:

Vox Sanguinis, 2006, v. 91, n. 4, p. 331, doi. 10.1111/j.1423-0410.2006.00820.x

By:

Lucey, C.

Publication type:

Article

United States Food and Drug Administration's authorization of reduced exposure claims for IQOS®: implications for regulation in Latin America.

Published in:

Pan American Journal of Public Health / Revista Panamericana de Salud Pública, 2022, v. 46, p. 1, doi. 10.26633/RPSP.2022.155

By:

Eckford, Robert;
Severini, Gianella;
Sebrié, Ernesto M.;
Muggli, Monique E.;
Beem, Alexandra;
Rosen, Debra;
Crosbie, Eric

Publication type:

Article

An evaluation of the Manufacturer And User Facility Device Experience database that inspired the United States Food and Drug Administration's Reclassification of transvaginal mesh.

Published in:

Investigative & Clinical Urology, 2018, v. 59, n. 2, p. 126, doi. 10.4111/icu.2018.59.2.126

By:

Sandberg, Jason M.;
Gray, Ian;
Pearlman, Amy;
Terlecki, Ryan P.

Publication type:

Article

美国食品药品监督管理局《慢性乙型肝炎病毒感染: 治疗药物的开发行业指南》的更新要点解读 (临床部分).

Published in:

Journal of Clinical Hepatology / Linchuang Gandanbing Zazhi, 2022, v. 38, n. 8, p. 1759, doi. 10.3969/j.issn.1001-5256.2022.08.008

By:

沙迪;
吴艺迪;
牛俊奇;
王美霞

Publication type:

Article

Drug‐Associated Acute Kidney Injury Identified in the United States Food and Drug Administration Adverse Event Reporting System Database.

Published in:

Pharmacotherapy, 2018, v. 38, n. 8, p. 785, doi. 10.1002/phar.2152

By:

Welch, Hanna K.;
Kellum, John A.;
Kane‐Gill, Sandra L.

Publication type:

Article

Pharmacogenomic Biomarker Information in Drug Labels Approved by the United States Food and Drug Administration: Prevalence of Related Drug Use.

Published in:

Pharmacotherapy, 2008, v. 28, n. 8, p. 992, doi. 10.1592/phco.28.8.992

By:

Frueh, Felix W.;
Amur, Shashi;
Mummaneni, Padmaja;
Epstein, Robert S.;
Aubert, Ronald E.;
DeLuca, Teresa M.;
Verbrugge, Robert R.;
Burckart, Gilbert J.;
Lesko, Lawrence J.

Publication type:

Article

基于美国 FAERS 数据库的儿童应用米诺环素发生药品不良事件的信号挖掘与分析.

Published in:

Evaluation & Analysis of Drug-Use in Hospitals of China / Zhongguo Yiyuan Yongyao Pingjia yu Fenxi, 2025, v. 25, n. 2, p. 244, doi. 10.14009/j.issn.1672-2124.2025.02.026

By:

关笑婵;
耿东丽;
钱奇芳;
段萌;
刘楠楠

Publication type:

Article

基于美国 FAERS 数据库的舒尼替尼相关药品不良事件信号挖掘与分析.

Published in:

Evaluation & Analysis of Drug-Use in Hospitals of China / Zhongguo Yiyuan Yongyao Pingjia yu Fenxi, 2025, v. 25, n. 1, p. 93, doi. 10.14009/j.issn.1672-2124.2025.01.021

By:

高媛;
张之晗;
王晓倩;
高美龄;
李从欣

Publication type:

Article

基于美国 FAERS 数据库的头孢曲松钠相关药品不良事件信号挖掘与分析.

Published in:

Evaluation & Analysis of Drug-Use in Hospitals of China / Zhongguo Yiyuan Yongyao Pingjia yu Fenxi, 2024, v. 24, n. 11, p. 1389, doi. 10.14009/j.issn.1672-2124.2024.11.021

By:

张坤;
邓燕;
欧阳冰;
蔡永青;
蒋婷婷;
刘耀

Publication type:

Article

基于美国 FAERS 数据库的多黏菌素 E 相关药品不良事件信号挖掘研究.

Published in:

Evaluation & Analysis of Drug-Use in Hospitals of China / Zhongguo Yiyuan Yongyao Pingjia yu Fenxi, 2024, v. 24, n. 10, p. 1257, doi. 10.14009/j.issn.1672-2124.2024.10.021

By:

杨欣彤;
章新晶;
江文静;
彭洪薇;
刘建明

Publication type:

Article

基于美国 FAERS 数据库对替度格鲁肽相关药品不良事件信号的挖掘与分析.

Published in:

Evaluation & Analysis of Drug-Use in Hospitals of China / Zhongguo Yiyuan Yongyao Pingjia yu Fenxi, 2024, v. 24, n. 10, p. 1272, doi. 10.14009/j.issn.1672-2124.2024.10.024

By:

李汶睿;
汪潇潇;
唐宗伟;
陈万-

Publication type:

Article

Right now, in the right way: U. S. Food and Drug Administration's expanded access program and patient rights.

Published in:

2018

By:

Blair Holbein, M. E.;
Weatherwax, Kevin J.;
Gravelin, Misty;
Hutchinsonz, Raymond;
Mashour, George A.

Publication type:

Editorial

Oncology Drug Development and Approval of Systemic Anticancer Therapy by the U.S. Food and Drug Administration.

Published in:

Oncologist, 2013, v. 18, n. 1, p. 104, doi. 10.1634/theoncologist.2012-0235

By:

Martell, Robert E.;
Sermer, David;
Getz, Kenneth;
Kaitin, Kenneth I.

Publication type:

Article

Type of E-Cigarette Device Used Among Adolescents and Young Adults: Findings From a Pooled Analysis of Eight Studies of 2166 Vapers.

Published in:

2018

By:

Barrington-Trimis, Jessica L.;
Gibson, Laura A.;
Halpern-Felsher, Bonnie;
Harrell, Melissa B.;
Kong, Grace;
Krishnan-Sarin, Suchitra;
Leventhal, Adam M.;
Loukas, Alexandra;
McConnell, Rob;
Weaver, Scott R.

Publication type:

journal article

U.S. Food and Drug Administration anticancer drug approval trends from 2016 to 2018 for lung, colorectal, breast, and prostate cancer.

Published in:

2020

By:

Ribeiro, Tatiane Bomfim;
Ribeiro, Adalton;
Rodrigues, Luíza de Oliveira;
Harada, Guilherme;
Nobre, Moacyr Roberto Cuce

Publication type:

journal article

An exploratory study evaluated the 30 most commonly reported medications in the United States food and drug administration's adverse event reporting system that are associated with the occurrence of kidney stones.

Published in:

Frontiers in Pharmacology, 2025, p. 1, doi. 10.3389/fphar.2024.1377679

By:

Bao, Erhao;
Yang, Yang;
Jiang, Binglei;
Wang, Ben;
Liu, Ying;
Yang, Lin;
Xia, Long;
Zhu, Pingyu

Publication type:

Article

The Mifepristone Litigation: Untangling the Implications of the Fifth Circuit's Decision for Abortion Access and the U.S. Food and Drug Administration.

Published in:

Annals of Internal Medicine, 2023, v. 176, n. 12, p. 1666, doi. 10.7326/M23-2431

By:

Zettler, Patricia J.;
Grossman, Lewis A.;
Adashi, Eli Y.;
Cohen, I. Glenn

Publication type:

Article

U.S. Food and Drug Administration Reasoning in Approval Decisions When Efficacy Evidence Is Borderline, 2013-2018.

Published in:

2021

By:

Janiaud, Perrine;
Irony, Telba;
Russek-Cohen, Estelle;
Goodman, Steven N.

Publication type:

journal article

Blueprint for Transparency at the U.S. Food and Drug Administration: Recommendations to Advance the Development of Safe and Effective Medical Products.

Published in:

Journal of Law, Medicine & Ethics, 2017, v. 45, p. 7, doi. 10.1177/1073110517750615

By:

Sharfstein, Joshua M.;
Miller, James Dabney;
Davis, Anna L.;
Ross, Joseph S.;
McCarthy, Margaret E.;
Smith, Brian;
Chaudhry, Anam;
Alexander, G. Caleb;
Kesselheim, Aaron S.

Publication type:

Article

U.S. Food and Drug Administration Approval Summary: Enzalutamide for the Treatment of Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer.

Published in:

Oncologist, 2015, v. 20, n. 8, p. 960, doi. 10.1634/theoncologist.2015-0166

By:

Ning, Yang‐Min;
Brave, Michael;
Maher, V. Ellen;
Zhang, Lijun;
Tang, Shenghui;
Sridhara, Rajeshwari;
Kim, Geoffrey;
Ibrahim, Amna;
Pazdur, Richard

Publication type:

Article

The U.S. Food and Drug Administration's Complex Innovative Trial Design Pilot Meeting Program: Progress to date.

Published in:

Clinical Trials, 2021, v. 18, n. 6, p. 706, doi. 10.1177/17407745211050580

By:

Price, Dionne;
Scott, John

Publication type:

Article

Health Literacy as Controversy: An Online Community’s Discussion of the U.S. Food and Drug Administration Acetaminophen Recommendations.

Published in:

Qualitative Health Research, 2011, v. 21, n. 12, p. 1607, doi. 10.1177/1049732311417731

By:

Mackert, Michael;
Love, Brad;
Donovan-Kicken, Erin;
Uhle, Katharine A.

Publication type:

Article

Artificial Intelligence and Machine Learning in the Diagnosis and Management of Stroke: A Narrative Review of United States Food and Drug Administration-Approved Technologies.

Published in:

Journal of Clinical Medicine, 2023, v. 12, n. 11, p. 3755, doi. 10.3390/jcm12113755

By:

Chandrabhatla, Anirudha S.;
Kuo, Elyse A.;
Sokolowski, Jennifer D.;
Kellogg, Ryan T.;
Park, Min;
Mastorakos, Panagiotis

Publication type:

Article

Serious Cutaneous Toxicities with Immune Checkpoint Inhibitors in the U.S. Food and Drug Administration Adverse Event Reporting System.

Published in:

Oncologist, 2019, v. 24, n. 11, p. e1228, doi. 10.1634/theoncologist.2019-0250

By:

Raschi, Emanuel;
Antonazzo, Ippazio Cosimo;
La Placa, Michelangelo;
Ardizzoni, Andrea;
Poluzzi, Elisabetta;
De Ponti, Fabrizio

Publication type:

Article

U.S. Food and Drug Administration Benefit‐Risk Assessment of Nilotinib Treatment Discontinuation in Patients with Chronic Phase Chronic Myeloid Leukemia in a Sustained Molecular Remission.

Published in:

Oncologist, 2019, v. 24, n. 5, p. e188, doi. 10.1634/theoncologist.2018-0759

By:

Pulte, E. Dianne;
Wroblewski, Tanya;
Bloomquist, Erik;
Tang, Shenghui;
Farrell, Ann;
Deisseroth, Albert;
McKee, Amy E.;
Pazdur, Richard

Publication type:

Article

U.S. Food and Drug Administration Approval Summary: Ramucirumab for the Treatment of Metastatic Non-Small Cell Lung Cancer Following Disease Progression On or After Platinum-Based Chemotherapy.

Published in:

Oncologist, 2015, v. 20, n. 11, p. 1320, doi. 10.1634/theoncologist.2015-0221

By:

Larkins, Erin;
Scepura, Barbara;
Blumenthal, Gideon M.;
Bloomquist, Erik;
Tang, Shenghui;
Biable, Missiratch;
Kluetz, Paul;
Keegan, Patricia;
Pazdur, Richard

Publication type:

Article

Erratum to: The Weber Effect and the United States Food and Drug Administration's Adverse Event Reporting System (FAERS): Analysis of Sixty-Two Drugs Approved from 2006 to 2010.

Published in:

Drug Safety, 2014, v. 37, n. 5, p. 381, doi. 10.1007/s40264-014-0159-6

By:

Hoffman, Keith;
Dimbil, Mo;
Erdman, Colin;
Tatonetti, Nicholas;
Overstreet, Brian

Publication type:

Article

Long Term Trends in Postoperative Outcomes and Route of Benign and Fibroid Hysterectomies After U.S. Food and Drug Administration Statement on Power Morcellators.

Published in:

Journal of Gynecologic Surgery, 2024, v. 40, n. 1, p. 32, doi. 10.1089/gyn.2023.0056

By:

Fox, Veronica S.;
Harvey, Lara F.B.;
Zhao, Zhiguo;
Chaves, Katherine F.;
Curlin, Howard L.;
Fajardo, Olga M.

Publication type:

Article

U.S. Food and Drug Administration Updates in Nutrition Labeling: What Clinicians Need to Know.

Published in:

Annals of Internal Medicine, 2024, v. 177, n. 4, p. 532, doi. 10.7326/M23-3266

By:

Warraich, Haider J.;
Carroll, Laura;
McKinnon, Robin A.;
Kavanaugh, Claudine;
Califf, Robert M.

Publication type:

Article

A Proposal by the U.S. Food and Drug Administration for Reliance on Single Institutional Review Boards: Proceed Only With Caution.

Published in:

Annals of Internal Medicine, 2024, v. 177, n. 3, p. 383, doi. 10.7326/M23-2152

By:

Spellecy, Ryan;
Thompson, Nathan;
Nattinger, Ann B.

Publication type:

Article

Participant Recruitment From Low- and Middle-Income Countries for Pivotal Trials of Drugs Approved by the U.S. Food and Drug Administration : A Cross-Sectional Analysis.

Published in:

Annals of Internal Medicine, 2022, v. 175, n. 12, p. 1675, doi. 10.7326/M22-1857

By:

Awan, Fareed A.;
Becker, Andrew B.;
Wang, Yuetong;
Kimmelman, Jonathan

Publication type:

Article

Organizational Reputation and Jurisdictional Claims: The Case of the U.S. Food and Drug Administration.

Published in:

Governance, 2010, v. 23, n. 1, p. 133, doi. 10.1111/j.1468-0491.2009.01470.x

By:

MAOR, MOSHE

Publication type:

Article

AGENDA-BUILDING INFLUENCES ON THE NEWS MEDIA'S COVERAGE OF THE U.S. FOOD AND DRUG ADMINISTRATION'S PUSH TO REGULATE TOBACCO, 1993-2009.

Published in:

Journal of Health & Human Services Administration, 2012, v. 35, n. 3, p. 303, doi. 10.1177/107937391203500304

By:

FOSTER, CAROLINE;
THRASHER, JIM;
KIM, SEI-HILL;
ROSE, INDIA;
BESLEY, JOHN;
NAVARRO, ASHLEY

Publication type:

Article

Hepatotoxicity Due to Troglitazone: Report of Two Cases and Review of Adverse Events Reported to the United States Food and Drug Administration.

Published in:

American Journal of Gastroenterology (Springer Nature), 2000, v. 95, n. 1, p. 272, doi. 10.1111/j.1572-0241.2000.01707.x

By:

Kohlroser, James;
Mathai, Jijy;
Reichheld, James;
Banner, Barbara F.;
Bonkovsky, Herbert L.

Publication type:

Article

Opioid exposure associated with poppy consumption reported to poison control centers and the U.S. Food and Drug Administration.

Published in:

Clinical Toxicology (15563650), 2021, v. 59, n. 8, p. 746, doi. 10.1080/15563650.2020.1866766

By:

Greenthal, Eva;
Lurie, Peter;
Doyon, Suzanne

Publication type:

Article

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.

Published in:

BMC Oral Health, 2024, v. 24, n. 1, p. 1, doi. 10.1186/s12903-024-04358-8

By:

Buldur, Mehmet;
Sezer, Berkant

Publication type:

Article

Impact of a New Consumer Form on the Quantity and Quality of Adverse Event Reports Submitted to the United States Food and Drug Administration.

Published in:

Pharmacotherapy, 2019, v. 39, n. 11, p. 1042, doi. 10.1002/phar.2325

By:

Muñoz, Monica A.;
Delcher, Chris;
Dal Pan, Gerald J.;
Kortepeter, Cindy M.;
Wu, Eileen;
Wei, Yu‐Jung Jenny;
Xiao, Hong;
Winterstein, Almut G

Publication type:

Article

Transparency at the U.S. Food and Drug Administration.

Published in:

Journal of Law, Medicine & Ethics, 2017, v. 45, p. 24, doi. 10.1177/1073110517750616

By:

Califf, Robert M.

Publication type:

Article

U.S. Food and Drug Administration Approval Summary: Omacetaxine Mepesuccinate as Treatment for Chronic Myeloid Leukemia.

Published in:

Oncologist, 2014, v. 19, n. 1, p. 94, doi. 10.1634/theoncologist.2013-0077

By:

Alvandi, Firoozeh;
Kwitkowski, Virginia E.;
Ko, Chia‐Wen;
Rothmann, Mark D.;
Ricci, Stacey;
Saber, Haleh;
Ghosh, Debasis;
Brown, Janice;
Pfeiler, Erika;
Chikhale, Elsbeth;
Grillo, Joseph;
Bullock, Julie;
Kane, Robert;
Kaminskas, Edvardas;
Farrell, Ann T.;
Pazdur, Richard

Publication type:

Article

The Role of the U.S. Food and Drug Administration Review Process: Clinical Trial Endpoints in Oncology.

Published in:

Oncologist, 2010, v. 15, p. 13, doi. 10.1634/theoncologist.2010-S1-13

By:

McKee, Amy E.;
Farrell, Ann T.;
Pazdur, Richard;
Woodcock, Janet

Publication type:

Article

Vaccines, Pharmaceutical Products, and Bioterrorism: Challenges for the U.S. Food and Drug Administration.

Published in:

Emerging Infectious Diseases, 1999, v. 5, n. 4, p. 534, doi. 10.3201/eid0504.990414

By:

Zoon, Kathryn C.

Publication type:

Article

U.S. Food and Drug Administration Launches New AER Tracking System.

Published in:: HerbalGram, 2002, n. 56, p. 1
Publication type:: Article

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

Published in:

Pharmaceuticals (14248247), 2023, v. 16, n. 1, p. 98, doi. 10.3390/ph16010098

By:

Zheng, Yi;
Guo, Xiaojing;
Chen, Chenxin;
Chi, Lijie;
Guo, Zhijian;
Liang, Jizhou;
Wei, Lianhui;
Chen, Xiao;
Ye, Xiaofei;
He, Jia

Publication type:

Article

Qualified Health Claims for Calcium and Colorectal, Breast, and Prostate Cancers: The U.S. Food and Drug Administration's Evidence-Based Review.

Published in:

Nutrition & Cancer, 2009, v. 61, n. 2, p. 157, doi. 10.1080/01635580802395741

By:

Kavanaugh, ClaudineJ.;
Trumbo, PaulaR.;
Ellwood, KathleenC.

Publication type:

Article

Injection-Site Nodules Associated With the Use of Exenatide Extended-Release Reported to the U.S. Food and Drug Administration Adverse Event Reporting System.

Published in:

Diabetes Spectrum, 2015, v. 28, n. 4, p. 283, doi. 10.2337/diaspect.28.4.283

By:

Jones, S. Christopher;
Ryan, Debra L.;
Pratt, Valerie S. W.;
Niak, Ali;
Brinker, Allen D.

Publication type:

Article

How Media Stories in Low- and Middle-Income Countries Discussed the U.S. Food and Drug Administration's Modified Risk Tobacco Product Order for IQOS.

Published in:

Nicotine & Tobacco Research, 2023, v. 25, n. 10, p. 1659, doi. 10.1093/ntr/ntad092

By:

Robichaud, Meagan O;
Puryear, Tyler;
Cohen, Joanna E;
Kennedy, Ryan David

Publication type:

Article

An Analysis of Twitter Posts About the U.S. Food and Drug Administration's Menthol Ban.

Published in:

Nicotine & Tobacco Research, 2023, v. 25, n. 5, p. 962, doi. 10.1093/ntr/ntac290

By:

Allem, Jon-Patrick;
Donaldson, Scott I;
Vogel, Erin A;
Pang, Raina D;
Unger, Jennifer B

Publication type:

Article

The complex pathway to United States Food and Drug Administration approval of Smoflipid.

Published in:: JPEN Journal of Parenteral & Enteral Nutrition, 2022, v. 46, n. 4, p. 748, doi. 10.1002/jpen.2262
Publication type:: Article

Evaluating the Impact of U.S. Food and Drug Administration–Proposed Nutrition Facts Label Changes on Young Adults’ Visual Attention and Purchase Intentions.

Published in:

Health Education & Behavior, 2016, v. 43, n. 4, p. 389, doi. 10.1177/1090198116651082

By:

Graham, Dan J.;
Roberto, Christina A.

Publication type:

Article

Precision Medicine, Diabetes, and the U.S. Food and Drug Administration.

Published in:

2016

By:

Meyer, Robert J.

Publication type:

journal article