Works matching U.S. Food and Drug Administration (FDA)

Results: 5000

Interview with Dr William Slikker Jr., Ph.D., Former Director, National Center for Toxicological Research, U.S. Food and Drug Administration (FDA), USA.

Published in:

2022

By:

Dobran, Stefana-Andrada;
Gherman, Alexandra

Publication type:

Interview

Acute stroke therapy with tissue plasminogen activator (tPA) since it was approved by the U.S. Food and Drug Administration (FDA).

Published in:

Annals of Neurology, 2009, v. 66, n. 1, p. 6, doi. 10.1002/ana.21750

By:

Zivin, Justin A.

Publication type:

Article

Scientific and Regulatory Policy Committee Points to Consider: Review of the United States Food and Drug Administration (FDA) Guidance on Pathology Peer Review in Nonclinical Toxicology Studies.

Published in:

Toxicologic Pathology, 2024, v. 52, n. 2/3, p. 138, doi. 10.1177/01926233241248654

By:

McDorman, Kevin S.;
Bennet, Bindu M.;
Colman, Karyn;
Fikes, James D.;
Keirstead, Natalie D.;
Lanning, Lynda;
Munch, Barbara;
Romeike, Annette;
Schafer, Kenneth A.;
Schorsch, Frédéric;
Thibodeau, Michael S.;
Thomas, Heath C.;
Troth, Sean;
Vahle, John L.;
Geoly, Frank J.

Publication type:

Article

U.S. Food and Drug Administration (FDA) Proposes Health Claim for Oatmeal and Oat Bran.

Published in:: Nutrition Reviews, 1996, v. 54, n. 2, p. 69
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

The USA Food and Drug Administration (FDA) does urological research a favour?

Published in:

BJU International, 2011, v. 108, n. 5, p. E157, doi. 10.1111/j.1464-410X.2011.10575.x

By:

Wyllie, Michael G.

Publication type:

Article

The United States Food and Drug Administration (FDA) regulatory response to combat neglected tropical diseases (NTDs): A review.

Published in:

PLoS Neglected Tropical Diseases, 2023, v. 16, n. 1, p. 1, doi. 10.1371/journal.pntd.0011010

By:

Mukherjee, Sanjana

Publication type:

Article

The U.S. Food and Drug Administration (FDA) Food Disaggregation Database (FDA-FDD): a new tool for U.S. dietary exposure assessment.

Published in:

Food Additives & Contaminants. Part A: Chemistry, Analysis, Control, Exposure & Risk Assessment, 2024, v. 41, n. 11, p. 1385, doi. 10.1080/19440049.2024.2393789

By:

Spungen, Judith H.;
Shimizu, Miyuki;
Jarman, Dwayne;
Santillana Farakos, Sofia M.

Publication type:

Article

U.S. Food and Drug Administration (FDA) proposes health claim for oatmeal and oat bran.

Published in:: 1996
Publication type:: Journal Article

Reported infections after human tissue transplantation before and after new food and drug administration (FDA) regulations, United States, 2001 through June, 2010.

Published in:

Cell & Tissue Banking, 2012, v. 13, n. 2, p. 259, doi. 10.1007/s10561-011-9253-5

By:

Mallick, Tarun;
Mosquera, Alexis;
Zinderman, Craig;
Martin, Laura;
Wise, Robert

Publication type:

Article

A review of bridging clinical studies between different presentations of biological products approved by the United States Food and Drug Administration (US FDA).

Published in:

Expert Opinion on Biological Therapy, 2022, v. 22, n. 10, p. 1293, doi. 10.1080/14712598.2022.2113053

By:

Patel, Ronak;
Ghadge, Pravin;
Nair, Pravin A.;
Kumar, Manish;
Adhikary, Laxmi

Publication type:

Article

Guest speaker at a U.S. Food & Drug Administration (FDA) panel meeting Washington DC 20 & 21 September 2016.

Published in:

2016

By:

Gottrup, Finn

Publication type:

Proceeding

Smart Tots: a public-private partnership between the United States Food and Drug Administration ( FDA) and the International Anesthesia Research Society ( IARS).

Published in:

Pediatric Anesthesia, 2012, v. 22, n. 10, p. 969, doi. 10.1111/pan.12014

By:

Ramsay, James G.;
Roizen, Michael;
Davidson, Andrew

Publication type:

Article

American Epilepsy Society (AES): Written Comments to Norman E. "Ned" Sharpless, MD, Acting Commissioner of Food and Drugs, U.S. Food and Drug Administration (FDA), Department of Health and Human Services (HHS): on Docket ID# FDA-2019-N-1482, Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing; Request for Comments : Submitted on: July 16, 2019

Published in:

Epilepsy Currents, 2019, v. 19, n. 6, p. 361, doi. 10.1177/1535759719878716

By:

Welty, Timothy E.;
Chapman, Kevin E.;
Faught, R. Edward;
Kotloski, Robert J.

Publication type:

Article

U.S. Food and Drug Administration (FDA) Approves Exelon.

Published in:: American Journal of Alzheimer's Disease & Other Dementias, 2007, v. 22, n. 2, p. 146
Publication type:: Article

Recognizing barriers to entry of biosimilars in the United States market and highlighting the solutions.

Published in:

Journal of Generic Medicines, 2021, v. 17, n. 3, p. 122, doi. 10.1177/1741134320972155

By:

Bana, Arpit;
Mehta, Priti J

Publication type:

Article

Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study.

Published in:

2018

By:

Wallach, Joshua D.;
Ciani, Oriana;
Pease, Alison M.;
Gonsalves, Gregg S.;
Krumholz, Harlan M.;
Taylor, Rod S.;
Ross, Joseph S.

Publication type:

journal article

Representation of Women and Minorities in Clinical Trials for New Molecular Entities and Original Therapeutic Biologics Approved by FDA CDER from 2013 to 2015.

Published in:

Journal of Women's Health (15409996), 2018, v. 27, n. 4, p. 418, doi. 10.1089/jwh.2016.6272

By:

Chen, Alice;
Wright, Hilary;
Itana, Hawi;
Elahi, Merina;
Igun, Ayomide;
Soon, Guoxing;
Pariser, Anne R.;
Fadiran, Emmanuel O.

Publication type:

Article

FDA Grants Accelerated Approval to Combination Avutometinib and Defactinib for KRAS-Variant, Recurrent, Low-Grade Serous Ovarian Cancer.

Published in:: ONS Voice, 2025, p. N.PAG
Publication type:: Article

United States National Library of Medicine Drug Information Portal.

Published in:

Medical Reference Services Quarterly, 2009, v. 28, n. 2, p. 154, doi. 10.1080/02763860902816784

By:

Hochstein, Colette;
Goshorn, Jeanne;
Chang, Florence

Publication type:

Article

Cancer mutation profiles predict ICIs efficacy in patients with non-small cell lung cancer.

Published in:

Expert Reviews in Molecular Medicine, 2022, v. 24, p. 1, doi. 10.1017/erm.2022.9

By:

Zhu, Liping;
Ye, Dafu;
Lei, Tianyu;
Wu, Jie;
Wang, Wei;
Xu, Bin

Publication type:

Article

Intravenous immunoglobulin therapy: usage patterns and response to treatment in Qatar over ten years.

Published in:

Frontiers in Immunology, 2024, p. 1, doi. 10.3389/fimmu.2024.1481079

By:

Taha, Salma A.;
Thalappil, Sherin;
Ali, Ramzy M.;
Fatima, Haajra;
Imameldin, Asaad Omer A.;
Aqel, Sami;
Abdelaal, Ahmed M.;
Siepmann, Timo;
Barlinn, Jessica;
Al-Nesf, Maryam A.

Publication type:

Article

Use of Population Pharmacokinetic Analyses Among FDA‐Approved Biologics.

Published in:

Clinical Pharmacology in Drug Development, 2019, v. 8, n. 7, p. 914, doi. 10.1002/cpdd.658

By:

Ogasawara, Ken;
Alexander, G. Caleb

Publication type:

Article

FDA Issues Early Alert for BD Intravascular PICC Catheter.

Published in:: ONS Voice, 2025, p. N.PAG
Publication type:: Article

FDA Approves Penpulimab-Kcqx for Non-Keratinizing Nasopharyngeal Carcinoma.

Published in:: ONS Voice, 2025, p. N.PAG
Publication type:: Article

FDA Approves Nivolumab With Ipilimumab for Unresectable or Metastatic Hepatocellular Carcinoma.

Published in:: ONS Voice, 2025, p. N.PAG
Publication type:: Article

FDA Approves Nivolumab With Ipilimumab for Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer.

Published in:: ONS Voice, 2025, p. N.PAG
Publication type:: Article

FDA Approves Nivolumab With Ipilimumab for Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer.

Published in:: ONS Voice, 2025, p. N.PAG
Publication type:: Article

FDA Approves Pembrolizumab for HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD-L1 (CPS ≥ 1).

Published in:: ONS Voice, 2025, p. N.PAG
Publication type:: Article

FDA Approves Durvalumab for Muscle-Invasive Bladder Cancer.

Published in:: ONS Voice, 2025, p. N.PAG
Publication type:: Article

FDA Expands Radiopharmaceutical's Metastatic Castration-Resistant Prostate Cancer Indication.

Published in:: ONS Voice, 2025, p. N.PAG
Publication type:: Article

FDA Approves Cabozantinib for Adults and Pediatric Patients Aged 12 And Older With pNET and epNET.

Published in:: ONS Voice, 2025, p. N.PAG
Publication type:: Article

More Than 19 Million People Could Quit Smoking in 5 Years With Nicotine Reduction Rule.

Published in:: ONS Voice, 2025, p. N.PAG
Publication type:: Article

FDA Expands Radiopharmaceutical's Metastatic Castration-Resistant Prostate Cancer Indication.

Published in:: ONS Voice, 2025, p. N.PAG
Publication type:: Article

FDA Announces Multi-Manufacturer Lot Withdrawals of IV and SC Immune Globulin.

Published in:: ONS Voice, 2025, p. N.PAG
Publication type:: Article

FDA Issues Early Alert for Baxter Healthcare Corporation Infusion Pump Issue.

Published in:: ONS Voice, 2025, p. N.PAG
Publication type:: Article

FDA Announces BD's Voluntary Worldwide Recall for One Lot of ChloraPrep™ Clear 1 ml Applicators.

Published in:: ONS Voice, 2025, p. N.PAG
Publication type:: Article

FDA Approves Vimseltinib for Symptomatic Tenosynovial Giant Cell Tumor.

Published in:: ONS Voice, 2025, p. N.PAG
Publication type:: Article

FDA Approves Brentuximab Vedotin With Lenalidomide and Rituximab for Relapsed or Refractory Large B-Cell Lymphoma.

Published in:: ONS Voice, 2025, p. N.PAG
Publication type:: Article

FDA Approves Mirdametinib for Patients With Neurofibromatosis Type 1 Symptomatic Plexiform Neurofibromas Not Amenable to Complete Resection.

Published in:: ONS Voice, 2025, p. N.PAG
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 overview of upcoming changes in pregnancy and lactation labeling information.

Published in:

Pharmacy Practice (1886-3655), 2015, v. 13, n. 2, p. 1, doi. 10.18549/PharmPract.2015.02.605

By:

MOSLEY II, Juan F.;
SMITH, Lillian L.;
DEZAN, Megan D.

Publication type:

Article

İLAÇ İLAÇ ETKİLEŞİMLERİNİN JORDAN ELMAN AĞLARI KULLANILARAK SINIFLANDIRILMASI.

Published in:

Journal of the Faculty of Engineering & Architecture of Gazi University / Gazi Üniversitesi Mühendislik Mimarlık Fakültesi Dergisi,, 2014, v. 29, n. 1, p. 149

By:

HARDALAÇ, Fırat;
KUTBAY, Uğurhan

Publication type:

Article

Handlungsempfehlungen zur Gentherapie der spinalen Muskelatrophie mit Onasemnogene Abeparvovec – AVXS-101: Konsensuspapier der deutschen Vertretung der Gesellschaft für Neuropädiatrie (GNP) und der deutschen Behandlungszentren unter Mitwirkung des Medizinisch-Wissenschaftlichen Beirates der Deutschen Gesellschaft für Muskelkranke (DGM) e. V

Published in:

Der Nervenarzt, 2020, v. 91, n. 6, p. 518, doi. 10.1007/s00115-020-00919-8

By:

Ziegler, Andreas;
Wilichowski, Ekkehard;
Schara, Ulrike;
Hahn, Andreas;
Müller-Felber, Wolfgang;
Johannsen, Jessika;
von der Hagen, Maja;
von Moers, Arpad;
Stoltenburg, Corinna;
Saffari, Afshin;
Walter, Maggie C.;
Husain, Ralf A.;
Pechmann, Astrid;
Köhler, Cornelia;
Horber, Veronka;
Schwartz, Oliver;
Kirschner, Janbernd

Publication type:

Article

Gentherapien für neuromuskuläre Erkrankungen.

Published in:

Der Nervenarzt, 2019, v. 90, n. 8, p. 809, doi. 10.1007/s00115-019-0761-z

By:

Saffari, Afshin;
Weiler, Markus;
Hoffmann, Georg Friedrich;
Ziegler, Andreas

Publication type:

Article

Liposomales Bupivacain – kein Durchbruch in der postoperativen Schmerztherapie.

Published in:

Die Anaesthesiologie, 2022, v. 71, n. 7, p. 556, doi. 10.1007/s00101-022-01118-7

By:

Otremba, Berit;
Dinges, Hanns-Christian;
Schubert, Ann-Kristin;
Zink, Wolfgang;
Steinfeldt, Thorsten;
Wulf, Hinnerk;
Wiesmann, Thomas

Publication type:

Article

Performance evaluation methods for improvements at post-market of artificial intelligence/machine learning-based computer-aided detection/diagnosis/triage in the United States.

Published in:

PLoS Digital Health, 2023, v. 1, n. 3, p. 1, doi. 10.1371/journal.pdig.0000209

By:

Yuba, Mitsuru;
Iwasaki, Kiyotaka

Publication type:

Article

Adverse event profiles of CDK4/6 inhibitors: data mining and disproportionality analysis of the FDA adverse event reporting system.

Published in:

Therapeutic Advances in Drug Safety, 2024, v. 15, p. 1, doi. 10.1177/20420986241278498

By:

Shen, Jun;
Luo, Pingli;
Xu, Jianmei

Publication type:

Article

Tissue-Agnostic Targeting of Neurotrophic Tyrosine Receptor Kinase Fusions: Current Approvals and Future Directions.

Published in:

Cancers, 2024, v. 16, n. 19, p. 3395, doi. 10.3390/cancers16193395

By:

Gouda, Mohamed A.;
Thein, Kyaw Z.;
Hong, David S.

Publication type:

Article

Assessment of a Size-Based Method for Enriching Circulating Tumour Cells in Colorectal Cancer.

Published in:

Cancers, 2022, v. 14, n. 14, p. N.PAG, doi. 10.3390/cancers14143446

By:

Vasantharajan, Sai Shyam;
Barnett, Edward;
Gray, Elin S.;
McCall, John L.;
Rodger, Euan J.;
Eccles, Michael R.;
Munro, Fran;
Pattison, Sharon;
Chatterjee, Aniruddha

Publication type:

Article