Works matching DE "CENTER for Drug Evaluation %26 Research (U.S.)"
Results: 75
Pharmacy 101.
- Published in:
- Inside MS, 2005, v. 23, n. 1, p. 42
- By:
- Publication type:
- Article
Examination of the Relationship Between Oncology Drug Labeling Revision Frequency and FDA Product Categorization.
- Published in:
- American Journal of Public Health, 2009, v. 99, n. 9, p. 1693, doi. 10.2105/AJPH.2008.141010
- By:
- Publication type:
- Article
Cardiovascular Risk Assessment in the Development of New Drugs for Obesity.
- Published in:
- 2012
- By:
- Publication type:
- Proceeding
Agency on hiring spree.
- Published in:
- Nature Biotechnology, 2008, v. 26, n. 6, p. 596, doi. 10.1038/nbt0608-596a
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- Publication type:
- Article
For opiate management, FDA pledges to balance enforcement, palliative care needs.
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- American Journal of Health-System Pharmacy, 2009, v. 66, n. 11, p. 968, doi. 10.2146/news090046
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- Publication type:
- Article
Orphan Drug Act passes quarter-century milestone in fight against rare diseases.
- Published in:
- American Journal of Health-System Pharmacy, 2008, v. 65, n. 13, p. 1205, doi. 10.2146/news080054
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- Publication type:
- Article
CDER Must Have Clinical Trial Reform.
- Published in:
- Bio-IT World, 2011, v. 10, n. 5, p. 58
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- Publication type:
- Article
The First Nine Months.
- Published in:
- Bio-IT World, 2008, v. 7, n. 7, p. 31
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- Publication type:
- Article
Resolutions Around Regulatory Compliance.
- Published in:
- 2008
- By:
- Publication type:
- Editorial
Conflict of interest and resignation at drug agency.
- Published in:
- Nature, 2009, v. 460, n. 7258, p. 943, doi. 10.1038/460943e
- Publication type:
- Article
News in brief.
- Published in:
- 2006
- Publication type:
- Other
Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.
- Published in:
- 2017
- By:
- Publication type:
- journal article
Regulatory Forum Commentary Counterpoint: Dose Selection for rasH2 Mouse Carcinogenicity Studies.
- Published in:
- Toxicologic Pathology, 2015, v. 43, n. 5, p. 628, doi. 10.1177/0192623315578012
- By:
- Publication type:
- Article
Food and Drug Administration, Center for Drug Evaluation and Research.
- Published in:
- Toxicologic Pathology, 2007, v. 35, n. 2, p. 323, doi. 10.1080/01926230701226575
- By:
- Publication type:
- Article
Paving the critical path of drug development: the CDER perspective.
- Published in:
- Nature Reviews Drug Discovery, 2014, v. 13, n. 11, p. 783, doi. 10.1038/nrd4435
- By:
- Publication type:
- Article
2013 FDA drug approvals.
- Published in:
- Nature Reviews Drug Discovery, 2014, v. 13, n. 2, p. 85, doi. 10.1038/nrd4239
- By:
- Publication type:
- Article
Guest editor’s note: Special issue on biosimilarity assessment.
- Published in:
- Journal of Biopharmaceutical Statistics, 2017, v. 27, n. 2, p. 195, doi. 10.1080/10543406.2017.1272396
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- Publication type:
- Article
Concomitant Use of Ibuprofen and Aspirin.
- Published in:
- Journal of Pain & Palliative Care Pharmacotherapy, 2007, v. 21, n. 2, p. 73, doi. 10.1300/J354v21n02_14
- Publication type:
- Article
FDA PLAN TO STRENGTHEN ADVISORY COMMITTEE PROCESSES.
- Published in:
- Journal of Pain & Palliative Care Pharmacotherapy, 2007, v. 21, n. 1, p. 113
- Publication type:
- Article
Institute of Medicine report calls for extensive overhaul of drug safety procedures at FDA, CDER.
- Published in:
- Formulary, 2006, v. 41, n. 11, p. 607
- By:
- Publication type:
- Article
FDA Establishes New Cancer Office and Program.
- Published in:
- ONS News, 2004, v. 19, n. 9, p. 14
- Publication type:
- Article
From the FDA.
- Published in:
- Brown University Child & Adolescent Psychopharmacology Update, 2009, v. 11, n. 3, p. 8
- Publication type:
- Article
Novel Drugs Passed Muster in 2016.
- Published in:
- 2017
- By:
- Publication type:
- journal article
News From the Food and Drug Administration.
- Published in:
- JAMA: Journal of the American Medical Association, 2017, v. 317, n. 7, p. 688, doi. 10.1001/jama.2017.0453
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- Publication type:
- Article
Generic Drugs Making Waves.
- Published in:
- Applied Clinical Trials, 2012, v. 21, n. 11, p. 12
- By:
- Publication type:
- Article
FDA Gains Support for e-Submissions, Standards.
- Published in:
- Applied Clinical Trials, 2011, v. 20, n. 6, p. 18
- By:
- Publication type:
- Article
Notes from the FDA.
- Published in:
- Applied Clinical Trials, 2008, v. 17, n. 11, p. 50
- By:
- Publication type:
- Article
Search for Stability at FDA.
- Published in:
- 2005
- By:
- Publication type:
- Editorial
The Effect of Salient Reputational Threats on the Pace of FDA Enforcement.
- Published in:
- Governance, 2013, v. 26, n. 1, p. 31, doi. 10.1111/j.1468-0491.2012.01601.x
- By:
- Publication type:
- Article
Biomarkers for Chronic Obstructive Pulmonary Disease, Kidney Disease Qualify for Research.
- Published in:
- CTS: Clinical & Translational Science, 2015, v. 8, n. 6, p. 620, doi. 10.1111/cts.12349
- By:
- Publication type:
- Article
The FDA Regulatory Process for Drug and Genetic Diagnostic Test Approvals.
- Published in:
- 2008
- By:
- Publication type:
- Other
Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review.
- Published in:
- Clinical Pharmacology & Therapeutics, 2011, v. 89, n. 2, p. 259, doi. 10.1038/clpt.2010.298
- By:
- Publication type:
- Article
The Food and Drug Administration's Drug Safety Oversight Board: An Evolving Paradigm for Clinical Input on Drug Safety Topics.
- Published in:
- Clinical Pharmacology & Therapeutics, 2010, v. 88, n. 2, p. 269, doi. 10.1038/clpt.2010.82
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- Publication type:
- Article
How a US Regulator Can Encourage New Science.
- Published in:
- Clinical Pharmacology & Therapeutics, 2009, v. 86, n. 5, p. 471, doi. 10.1038/clpt.2009.188
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- Publication type:
- Article
The Institute of Medicine’s Report on Drug Safety: Constructive and Ambitious, But Does It Go Far Enough?
- Published in:
- Clinical Pharmacology & Therapeutics, 2007, v. 81, n. 2, p. 156, doi. 10.1038/sj.clpt.6100086
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- Publication type:
- Article
Highlights.
- Published in:
- Clinical Pharmacology & Therapeutics, 2007, v. 81, n. 1, p. 8, doi. 10.1038/sj.clpt.6100057
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- Publication type:
- Article
Advancing pharmaceutical quality oversight during the lifecycle of generic drug products.
- Published in:
- Journal of Generic Medicines, 2015, v. 12, n. 1, p. 26, doi. 10.1177/1741134315608909
- By:
- Publication type:
- Article
What evidence do we need for biomarker qualification?
- Published in:
- Science Translational Medicine, 2017, v. 9, n. 417, p. 1, doi. 10.1126/scitranslmed.aal4599
- By:
- Publication type:
- Article
Development and clinical testing of individual immunoassays for the quantification of serum glycoproteins to diagnose prostate cancer.
- Published in:
- PLoS ONE, 2017, v. 12, n. 8, p. 1, doi. 10.1371/journal.pone.0181557
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- Publication type:
- Article
PRODUCT UPDATE.
- Published in:
- Oncology Nursing Forum, 2005, v. 32, n. 1, p. 121, doi. 10.1188/05.ONF.121-122
- By:
- Publication type:
- Article
Biophysical Analysis of Lipopolysaccharide Formulations for an Understanding of the Low Endotoxin Recovery (LER) Phenomenon.
- Published in:
- International Journal of Molecular Sciences, 2017, v. 18, n. 12, p. 2737, doi. 10.3390/ijms18122737
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- Publication type:
- Article
Beneath the propaganda.
- Published in:
- Canadian Medical Association Journal (CMAJ), 2012, v. 184, n. 9, p. E482, doi. 10.1503/cmaj.109-4202
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- Publication type:
- Article
FDA says it must strengthen its scientific base to regulate drug safety.
- Published in:
- Canadian Medical Association Journal (CMAJ), 2011, v. 183, n. 12, p. E796
- By:
- Publication type:
- Article
Tainted weight-loss products.
- Published in:
- Canadian Medical Association Journal (CMAJ), 2009, v. 180, n. 9, p. 917, doi. 10.1503/cmaj.090580
- By:
- Publication type:
- Article
FDA Approves First Maintenance Drug Therapy for Advanced Lung Cancer.
- Published in:
- Oncology (08909091), 2009, v. 23, n. 10, p. 810
- Publication type:
- Article
Terminal node problems: ANT 2.0 and prescription drug labels.
- Published in:
- Technical Communication Quarterly, 2018, v. 27, n. 2, p. 121, doi. 10.1080/10572252.2018.1425482
- By:
- Publication type:
- Article
2012 FDA drug approvals.
- Published in:
- Nature Reviews Drug Discovery, 2013, v. 12, n. 2, p. 87, doi. 10.1038/nrd3946
- By:
- Publication type:
- Article
2011 FDA drug approvals.
- Published in:
- Nature Reviews Drug Discovery, 2012, v. 11, n. 2, p. 91, doi. 10.1038/nrd3657
- By:
- Publication type:
- Article
News in brief.
- Published in:
- Nature Reviews Drug Discovery, 2011, v. 10, n. 9, p. 647, doi. 10.1038/nrd3547
- Publication type:
- Article
2010 FDA drug approvals.
- Published in:
- Nature Reviews Drug Discovery, 2011, v. 10, n. 2, p. 82, doi. 10.1038/nrd3370
- By:
- Publication type:
- Article