Works matching DE "CENTER for Drug Evaluation %26 Research (U.S.)"

Results: 76

FDA Approves First Maintenance Drug Therapy for Advanced Lung Cancer.

Published in:: Oncology (08909091), 2009, v. 23, n. 10, p. 810
Publication type:: Article

CDER Must Have Clinical Trial Reform.

Published in:

Bio-IT World, 2011, v. 10, n. 5, p. 58

By:

RUSSELL, JOHN

Publication type:

Article

The First Nine Months.

Published in:

Bio-IT World, 2008, v. 7, n. 7, p. 31

By:

NEUER, ANN

Publication type:

Article

Resolutions Around Regulatory Compliance.

Published in:

2008

By:

Perry, Warren

Publication type:

Editorial

Battle looms over regulatory classification of complex drugs.

Published in:

Nature Medicine, 2012, v. 18, n. 4, p. 474, doi. 10.1038/nm0412-474b

By:

Hersher, Rebecca

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:

Rosencrance, Susan M.;
Wu, Geoffrey K.

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:

Kessler, Molly M.;
Graham, S. Scott

Publication type:

Article

FDA Establishes New Cancer Office and Program.

Published in:: ONS News, 2004, v. 19, n. 9, p. 14
Publication type:: Article

Novel Drugs Passed Muster in 2016.

Published in:

2017

By:

Voelker, Rebecca

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

By:

Voelker, Rebecca

Publication type:

Article

Cardiovascular Risk Assessment in the Development of New Drugs for Obesity.

Published in:

2012

By:

Hiatt, William R.;
Goldfine, Allison B.;
Kaul, Sanjay

Publication type:

Proceeding

FDA, Sponsors Continue Quest for More Efficient Clinical Trials.

Published in:

2014

By:

Wechsler, Jill

Publication type:

Opinion

PDUFA V Changes To Speed Drug Development and Approvals.

Published in:

Applied Clinical Trials, 2013, v. 22, n. 6, p. 10

By:

Wechsler, Iill

Publication type:

Article

FDA Promotes Quality and Risk Management.

Published in:

Applied Clinical Trials, 2013, v. 22, n. 4, p. 12

By:

Wechsler, Iill

Publication type:

Article

Generic Drugs Making Waves.

Published in:

Applied Clinical Trials, 2012, v. 21, n. 11, p. 12

By:

Henderson, Lisa

Publication type:

Article

FDA Gains Support for e-Submissions, Standards.

Published in:

Applied Clinical Trials, 2011, v. 20, n. 6, p. 18

By:

Wechsler, Jill

Publication type:

Article

Notes from the FDA.

Published in:

Applied Clinical Trials, 2008, v. 17, n. 11, p. 50

By:

Shapiro, Marissa

Publication type:

Article

Search for Stability at FDA.

Published in:

2005

By:

Wechsler, Jill

Publication type:

Editorial

2013 FDA drug approvals.

Published in:

Nature Reviews Drug Discovery, 2014, v. 13, n. 2, p. 85, doi. 10.1038/nrd4239

By:

Mullard, Asher

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:

Mullard, Asher

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:

Mullard, Asher

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:

Mullard, Asher

Publication type:

Article

2009 FDA drug approvals.

Published in:

Nature Reviews Drug Discovery, 2010, v. 9, n. 2, p. 89, doi. 10.1038/nrd3101

By:

Hughes, Bethan

Publication type:

Article

2008 FDA drug approvals.

Published in:

2009

By:

Hughes, Bethan

Publication type:

journal 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:

Nagy, Benjamin

Publication type:

Article

Food and drug administration approval process for dermatology drugs in the United States.

Published in:

Journal of Dermatological Treatment, 2018, v. 29, n. 6, p. 536, doi. 10.1080/09546634.2018.1425361

By:

Boozalis, Emily;
Kwatra, Shawn G.;
Semenov, Yevgeniy R.

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

By:

Endt, Kathrin;
Goepfert, Jens;
Omlin, Aurelius;
Athanasiou, Alcibiade;
Tennstedt, Pierre;
Guenther, Anna;
Rainisio, Maurizio;
Engeler, Daniel S.;
Steuber, Thomas;
Gillessen, Silke;
Joos, Thomas;
Schiess, Ralph

Publication type:

Article

FDA MODERNIZES CONTROLLED CORRESPONDENCE INTERACTIONS WITH INDUSTRY.

Published in:

Applied Clinical Trials, 2019, v. 28, n. 4, p. 7

By:

Middleton, Saundra;
Graborov, Daniil;
Hill, Shannon;
Marshall, Christina;
McNall, Marissa;
Miller, Kelly

Publication type:

Article

Patients, PDUFA, Pandemics to Shape Clinical Research in 2016.

Published in:

Applied Clinical Trials, 2015, v. 24, n. 12, p. 8

By:

Wechsler, Jill

Publication type:

Article

FDA Updates Policies to Continue Gains in New Drug Approvals.

Published in:

2015

By:

Wechsler, Jill

Publication type:

Opinion

Agency on hiring spree.

Published in:

Nature Biotechnology, 2008, v. 26, n. 6, p. 596, doi. 10.1038/nbt0608-596a

By:

Waltz, Emily

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:

Woodcock, Janet

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

By:

Chang, Victoria Yu-Wei;
Endrenyi, Laszlo

Publication type:

Article

Testing Method Performance.

Published in:

LC-GC Europe, 2009, v. 22, n. 3, p. 132

By:

Dolan, John W.

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:

Berlin, Robert J.

Publication type:

Article

Evaluating the Use of KIM‐1 in Drug Development and Research Following FDA Qualification.

Published in:

Clinical Pharmacology & Therapeutics, 2018, v. 104, n. 6, p. 1175, doi. 10.1002/cpt.1093

By:

Chen, Ru;
Sanyal, Sarmistha;
Thompson, Aliza;
Ix, Joachim H.;
Haskins, Kylie;
Muldowney, Laurie;
Amur, Shashi

Publication type:

Article

Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization.

Published in:

Clinical Pharmacology & Therapeutics, 2015, v. 98, n. 1, p. 34, doi. 10.1002/cpt.136

By:

Amur, S;
LaVange, L;
Zineh, I;
Buckman‐Garner, S;
Woodcock, J

Publication type:

Article

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:

Zhao, P.;
Zhang, L.;
Grillo, J. A.;
Liu, Q.;
Bullock, J. M.;
Moon, Y. J.;
Song, P.;
Brar, S. S.;
Madabushi, R.;
Wu, T. C.;
Booth, B. P.;
Rahman, N. A.;
Reynolds, K. S.;
Gil Berglund, E.;
Lesko, L. J.;
Huang, S.-M.

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

By:

Grandinetti, C. A.;
Osborne, S. F.

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

By:

Throckmorton, D. C.

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

By:

Jones, J. K.

Publication type:

Article

Highlights.

Published in:

Clinical Pharmacology & Therapeutics, 2007, v. 81, n. 1, p. 8, doi. 10.1038/sj.clpt.6100057

By:

Nathans, Carrie

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

From the FDA.

Published in:: Brown University Child & Adolescent Psychopharmacology Update, 2009, v. 11, n. 3, p. 8
Publication type:: Article

Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

Published in:

2017

By:

Schick, Andreas;
Miller, Kathleen;
Lanthier, Michael;
Dal Pan, Gerald;
Nardinelli, Clark;
Miller, Kathleen L

Publication type:

journal article

2011 AAPS Annual Meeting and Exposition KEYNOTE SPEAKER.

Published in:: Pharmaceutical Research, 2011, v. 28, n. 8, p. 2055, doi. 10.1007/s11095-011-0509-3
Publication type:: Article

Commentary on "Statistics at FDA: Reflections on the Past Six Years".

Published in:

Statistics in Biopharmaceutical Research, 2019, v. 11, n. 1, p. 15, doi. 10.1080/19466315.2018.1561511

By:

Chakravarty, Aloka G.

Publication type:

Article

Interpreting the Regulatory Perspective on Adaptive Designs.

Published in:

Statistics in Biopharmaceutical Research, 2018, v. 10, n. 2, p. 123, doi. 10.1080/19466315.2017.1422799

By:

Balser, John;
Chang, Mark;
Bliss, Robin

Publication type:

Article