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Management: Food and Drug Administration (FDA)

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Total 5166 results found since Jan 2013.

PD-L1 and Lung Cancer: The Era of Precision-ish Medicine?
Abstract The success of immune checkpoint inhibitor therapy in lung cancer, both in squamous and nonsquamous non-small cell carcinoma, has led to US Food and Drug Administration approval for 2 medications that have as part of their prescribing information an associated immunohistochemistry-based companion or complementary diagnostic test for programmed death ligand 1 (PD-L1). The intense interest in drug development in this area has resulted in additional agents with associated diagnostics looming on the horizon in 2016. In the era of precision medicine, the paradigm of paired molecular target and molecular test, ...
Source: Archives of Pathology and Laboratory Medicine - January 12, 2016 Category: Laboratory Medicine Authors: Borczuk AC, Allen TC Tags: Arch Pathol Lab Med Source Type: research

National Academy of Medicine and FDA select 4 individuals for 2016-2017 Tobacco Regulatory Science Fellows
( National Academies of Sciences, Engineering, and Medicine ) The National Academy of Medicine along with the US Food and Drug Administration's Center for Tobacco Products (CTP) have named the 2016-2017 class of FDA Tobacco Regulatory Science Fellows. Four individuals were selected through a highly selective national competition based on their exceptional, diverse professional qualifications to contribute to the work of CTP.
Source: EurekAlert! - Medicine and Health - July 25, 2016 Category: Global & Universal Source Type: news

National Academy of Medicine and FDA announce the 2017 Tobacco Regulatory Science Fellows
(National Academies of Sciences, Engineering, and Medicine) The National Academy of Medicine (NAM) along with the US Food and Drug Administration's Center for Tobacco Products (CTP) have named the 2017-2018 class of the FDA Tobacco Regulatory Science Fellows. Four individuals were selected through a highly selective national competition based on their exceptional, diverse professional qualifications to contribute to the work of CTP.
Source: EurekAlert! - Medicine and Health - July 28, 2017 Category: International Medicine & Public Health Source Type: news

National Academy of Medicine and FDA announce the 2018 Tobacco Regulatory Science Fellows
(National Academies of Sciences, Engineering, and Medicine) The National Academy of Medicine (NAM) along with the US Food and Drug Administration's Center for Tobacco Products (CTP) have named the 2018-2019 class of FDA Tobacco Regulatory Science Fellows. Six individuals were selected through a highly selective national competition based on their exceptional, diverse professional qualifications to contribute to the work of CTP.
Source: EurekAlert! - Medicine and Health - July 26, 2018 Category: International Medicine & Public Health Source Type: news

Nuts and Bolts of 177Lu-DOTATATE Administration in the Nuclear Medicine Division: Guidance from a Single Institute's Experience.
Authors: Abbott A, Sakellis CG, Andersen E, Kuzuhara Y, Gilbert L, Boyle K, Kulke MH, Chan JA, Jacene HA, Van den Abbeele AD Abstract [Lutetium-177-DOTA(0),Tyr(3)]octreotate (177Lu-DOTATATE) is a radiolabeled somatostatin analog that has been approved by the U.S. Food and Drug Administration for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors in adults. Radionuclide therapies have been administered for many years within nuclear medicine departments in North America. However, in comparison to other radiotherapies, 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT...
Source: Journal of Nuclear Medicine Technology - August 6, 2018 Category: Nuclear Medicine Tags: J Nucl Med Technol Source Type: research

Why Does Medicine Cost So Much? Here ’s How Drug Prices Are Set
From 2007 to 2016, Mylan raised the list price of its EpiPen about 500%, from just under $100 to more than $600. From 2002 to 2013, insulin prices more than tripled. From 2012 to 2019, the average price of AbbVie’s rheumatoid-arthritis drug Humira climbed from $19,000 a year to $60,000 a year—and that’s after rebates. These are dramatic examples of a systemwide problem: prices for brand-name drugs are rising at a rate that far outstrips inflation. What’s behind these rapid price hikes? It’s a simple question with a complicated answer that involves three central entities: drug manufacturers, ph...
Source: TIME: Health - April 9, 2019 Category: Consumer Health News Authors: Laura Entis Tags: Uncategorized medicine Source Type: news

National Academy of Medicine and FDA announce the 2019 Tobacco Regulatory Science Fellows
(National Academies of Sciences, Engineering, and Medicine) The National Academy of Medicine (NAM) along with the US Food and Drug Administration's Center for Tobacco Products (CTP) have named the 2019-2020 class of FDA Tobacco Regulatory Science Fellows. Four individuals were selected through a highly selective national competition based on their exceptional, diverse professional qualifications to contribute to the work of CTP.
Source: EurekAlert! - Medicine and Health - July 25, 2019 Category: International Medicine & Public Health Source Type: news

Application of Next Generation Sequencing in Laboratory Medicine.
Authors: Zhong Y, Xu F, Wu J, Schubert J, Li MM Abstract The rapid development of next-generation sequencing (NGS) technology, including advances in sequencing chemistry, sequencing technologies, bioinformatics, and data interpretation, has facilitated its wide clinical application in precision medicine. This review describes current sequencing technologies, including short- and long-read sequencing technologies, and highlights the clinical application of NGS in inherited diseases, oncology, and infectious diseases. We review NGS approaches and clinical diagnosis for constitutional disorders; summarize the applicat...
Source: Annals of Laboratory Medicine - August 26, 2020 Category: Laboratory Medicine Tags: Ann Lab Med Source Type: research

Keck Medicine physicians become first to implant epilepsy-controlling device
(University of Southern California - Health Sciences) On Dec. 18, Keck Medicine of USC became the world's first medical center to implant a responsive brain device newly approved by the Food and Drug Administration to treat epilepsy, with potential to help millions of people worldwide.
Source: EurekAlert! - Medicine and Health - December 19, 2013 Category: Global & Universal Source Type: news

Radiation Protection and Regulations for the Nuclear Medicine Physician
This article is intended to serve as a condensed guide for NM physicians who are in the process of applying for a radioactive materials license, establishing a new radiation protection program, or want to ensure continued compliance and maintenance of safety and security of licensed materials in the clinical or research settings.
Source: Seminars in Nuclear Medicine - May 1, 2014 Category: Radiology Authors: Man Yu Chen Source Type: research

Guidance for pharmacogenomic biomarker testing in labels of FDA-approved drugs
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Source: Genetics in Medicine - September 2, 2015 Category: Genetics & Stem Cells Authors: Alexandre VivotIsabelle BoutronPhilippe RavaudRaphaël Porcher Tags: biomarkers Food and Drug Administration genetic testing personalized medicine pharmacogenetics Source Type: research

The Clinical Relevance of Serum NDKA, NMDA, PARK7, and UFDP Levels with Phlegm-Heat Syndrome and Treatment Efficacy Evaluation of Traditional Chinese Medicine in Acute Ischemic Stroke.
Authors: Han X, Gao Y, Ma B, Gao Y, Sun Y, Jiang R, Wang Y Abstract According to the methods of Patient-Reported Outcome (PRO) based on the patient reports internationally and referring to U.S. Food and Drug Administration (FDA) guide, some scholars developed this PRO of stroke which is consistent with China's national conditions, and using it the feel of stroke patients was introduced into the clinical efficacy evaluation system of stoke. "Ischemic Stroke TCM Syndrome Factor Diagnostic Scale (ISTSFDS)" and "Ischemic Stroke TCM Syndrome Factor Evaluation Scale (ISTSFES)" were by "Major State Basic Research Developm...
Source: Evidence-based Complementary and Alternative Medicine - November 8, 2015 Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research

Nigeria: NAFDAC Shuts 16 Herbal Medicine Facilities
[Vanguard] The National Agency for Food and Drug Administration and Control (NAFDAC) has shut 16 herbal medicine facilities and seized products over illegal operations in Onitsha, Anambra.
Source: AllAfrica News: Health and Medicine - April 13, 2016 Category: African Health Source Type: news

Pharmacogenomic biomarkers as inclusion criteria in clinical trials of oncology-targeted drugs: a mapping of ClinicalTrials.gov
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Source: Genetics in Medicine - August 4, 2016 Category: Genetics & Stem Cells Authors: Alexandre Vivot Jacques Li Jean-David Zeitoun Samia Mourah Perrine Crequit Philippe Ravaud Rapha ël Porcher Tags: biomarkers clinical trials Food and Drug Administration personalized medicine pharmacogenomics Source Type: research

NARMS (National Antimicrobial Resistance Monitoring System) 2015 Integrated Report
U.S. Food and Drug Administration. 10/2017 This 14-page report marks the 20th year of the National Antimicrobial Resistance Monitoring System (NARMS), and focuses on antimicrobial resistance to drug classes that are most important to human medicine (generally, first- or second-line treatments), multidrug resistance, and specific co-resistance profiles of epidemiological importance. It reports on the large dataset on bacteria that NARMS generates from 14 distinct sources, and their resistances. (PDF)
Source: Disaster Lit: Resource Guide for Disaster Medicine and Public Health - October 24, 2017 Category: International Medicine & Public Health Authors: The U.S. National Library of Medicine Source Type: news