Thomas J Hwang

Thomas J Hwang

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Thomas J Hwang

Thomas J Hwang

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European Medicines Agency's Priority Medicines Scheme at 2 Years: An Evaluation of Clinical Studies Supporting Eligible Drugs.

Clin Pharmacol Ther 2020 Mar 22;107(3):541-552. Epub 2019 Nov 22.

Department of Health Policy, London School of Economics and Political Science, London, UK.

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http://dx.doi.org/10.1002/cpt.1669DOI Listing
March 2020

Pediatric Trials for Cancer Therapies With Targets Potentially Relevant to Pediatric Cancers.

J Natl Cancer Inst 2020 Mar;112(3):224-228

Pediatric Therapeutics and Regulatory Science Initiative, Computational Health Informatics Program, Boston Children's Hospital, Boston, MA.

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http://dx.doi.org/10.1093/jnci/djz207DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7073929PMC
March 2020

Prescription Opioid Epidemic and Trends in the Clinical Development of New Pain Medications.

Mayo Clin Proc 2019 12 2;94(12):2437-2443. Epub 2019 Nov 2.

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA. Electronic address:

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http://dx.doi.org/10.1016/j.mayocp.2019.05.015DOI Listing
December 2019

Lifecycle Regulation of Artificial Intelligence- and Machine Learning-Based Software Devices in Medicine.

JAMA 2019 Nov 22. Epub 2019 Nov 22.

Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jama.2019.16842DOI Listing
November 2019

Pre-market development times for biologic versus small-molecule drugs.

Nat Biotechnol 2019 07;37(7):708-711

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

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http://dx.doi.org/10.1038/s41587-019-0175-2DOI Listing
July 2019

Association between progression-free survival and patients' quality of life in cancer clinical trials.

Int J Cancer 2019 04 6;144(7):1746-1751. Epub 2018 Dec 6.

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA.

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http://dx.doi.org/10.1002/ijc.31957DOI Listing
April 2019

Evaluating New Rules on Transparency in Cancer Research and Drug Development.

JAMA Oncol 2019 Apr;5(4):461-462

Washington University School of Law, St Louis, Missouri.

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http://dx.doi.org/10.1001/jamaoncol.2018.7093DOI Listing
April 2019

Analysis of Proposed Medicare Part B to Part D Shift With Associated Changes in Total Spending and Patient Cost-Sharing for Prescription Drugs.

JAMA Intern Med 2019 03;179(3):374-380

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

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http://archinte.jamanetwork.com/article.aspx?doi=10.1001/jam
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http://dx.doi.org/10.1001/jamainternmed.2018.6417DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6439690PMC
March 2019

Major Events in the Life Course of New Drugs, 2000-2016.

N Engl J Med 2019 Mar;380(11):e12

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http://dx.doi.org/10.1056/NEJMp1806930DOI Listing
March 2019

Impact Of The Priority Review Voucher Program On Drug Development For Rare Pediatric Diseases.

Health Aff (Millwood) 2019 02;38(2):313-319

Aaron S. Kesselheim is an associate professor of medicine at Harvard Medical School and director of the Program on Regulation, Therapeutics, and Law in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School.

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http://dx.doi.org/10.1377/hlthaff.2018.05330DOI Listing
February 2019

Patient-Centered Cancer Drug Development: Clinical Trials, Regulatory Approval, and Value Assessment.

Am Soc Clin Oncol Educ Book 2019 Jan 17;39:374-387. Epub 2019 May 17.

6 Department of Oncology, Hospital de la Santa Creu i Sant Pau, Institut d'Investigació Biomèdica Sant Pau and Universitat Autònoma de Barcelona, Barcelona, Spain.

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http://dx.doi.org/10.1200/EDBK_242229DOI Listing
January 2019

Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines.

J Clin Oncol 2018 06 24;36(18):1805-1812. Epub 2018 Apr 24.

Thomas J. Hwang, Jessica M. Franklin, Julie C. Lauffenburger, Bishal Gyawali, Aaron S. Kesselheim, and Jonathan J. Darrow, Brigham and Women's Hospital and Harvard Medical School; Christopher T. Chen, Dana-Farber Cancer Institute, Boston, MA; and Bishal Gyawali, Nagoya University Graduate School of Medicine, Nagoya, Japan.

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http://ascopubs.org/doi/10.1200/JCO.2017.77.1592
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http://dx.doi.org/10.1200/JCO.2017.77.1592DOI Listing
June 2018

Precision Medicines Have Faster Approvals Based On Fewer And Smaller Trials Than Other Medicines.

Health Aff (Millwood) 2018 05;37(5):724-731

Aaron S. Kesselheim is an associate professor of medicine at Harvard Medical School and director of the Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School.

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http://dx.doi.org/10.1377/hlthaff.2017.1580DOI Listing
May 2018

Availability of paediatric information in European Medicines Agency approvals.

Lancet Child Adolesc Health 2018 05 12;2(5):e9. Epub 2018 Apr 12.

Center for Pediatric Therapeutics and Regulatory Science, and Computational Health Informatics Program, Boston Children's Hospital, Boston, MA, USA; Department of Pediatrics, Harvard Medical School, Boston, MA 02115, USA. Electronic address:

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http://dx.doi.org/10.1016/S2352-4642(18)30101-9DOI Listing
May 2018

Affordability and Price Increases of New Cancer Drugs in Clinical Guidelines, 2007-2016.

JNCI Cancer Spectr 2018 Apr 1;2(2):pky016. Epub 2018 Jun 1.

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA.

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http://dx.doi.org/10.1093/jncics/pky016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6649801PMC
April 2018

Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study.

PLoS Med 2018 03 1;15(3):e1002520. Epub 2018 Mar 1.

Computational Health Informatics Program, Boston Children's Hospital, Boston, Massachusetts, United States of America.

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http://dx.doi.org/10.1371/journal.pmed.1002520DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5832187PMC
March 2018

Improving the Study of New Medicines for Children With Rare Diseases.

JAMA Pediatr 2018 Jan;172(1):7-9

Computational Health Informatics Program (CHIP) and Division of Emergency Medicine, Boston Children's Hospital, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jamapediatrics.2017.4012DOI Listing
January 2018

Social Media Impact of the Food and Drug Administration's Drug Safety Communication Messaging About Zolpidem: Mixed-Methods Analysis.

JMIR Public Health Surveill 2018 Jan 5;4(1):e1. Epub 2018 Jan 5.

Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States.

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http://dx.doi.org/10.2196/publichealth.7823DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5775485PMC
January 2018

The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016.

JAMA 2017 12;318(21):2137-2138

Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jama.2017.14896DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5820715PMC
December 2017

Value-Based Pricing and State Reform of Prescription Drug Costs.

JAMA 2017 08;318(7):609-610

Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jama.2017.8255DOI Listing
August 2017

Ensuring Access to Injectable Generic Drugs - The Case of Intravesical BCG for Bladder Cancer.

N Engl J Med 2017 Apr;376(15):1401-1403

From the Department of Urology, University of Pittsburgh and Hillman Cancer Center, Pittsburgh (B.J.D.); and the Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston (T.J.H., A.S.K.).

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http://dx.doi.org/10.1056/NEJMp1615697DOI Listing
April 2017

The Pediatric Research Equity Act Moves Into Adolescence.

JAMA 2017 01;317(3):259-260

Computational Health Informatics Program, Boston Children's Hospital, Boston, Massachusetts3Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jama.2016.18131DOI Listing
January 2017

Failure of Investigational Drugs in Late-Stage Clinical Development and Publication of Trial Results.

JAMA Intern Med 2016 Dec;176(12):1826-1833

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jamainternmed.2016.6008DOI Listing
December 2016

Public referendum on drug prices in the US: will it bring relief?

BMJ 2016 Oct 31;355:i5657. Epub 2016 Oct 31.

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02120, USA

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http://dx.doi.org/10.1136/bmj.i5657DOI Listing
October 2016

Measuring the Value of New Medications and Implications for Medicare's Proposed Part B Drug Payment Model.

JAMA Oncol 2016 Sep;2(9):1125-6

PureTech, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jamaoncol.2016.2037DOI Listing
September 2016

Temporal Trends and Factors Associated With Cardiovascular Drug Development, 1990 to 2012.

JACC Basic Transl Sci 2016 Aug 29;1(5):301-308. Epub 2016 Aug 29.

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1016/j.jacbts.2016.03.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6113354PMC
August 2016

Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study.

BMJ 2016 Jun 28;353:i3323. Epub 2016 Jun 28.

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4925918PMC
http://dx.doi.org/10.1136/bmj.i3323DOI Listing
June 2016

Leveraging Novel and Existing Pathways to Approve New Therapeutics to Treat Serious Drug-Resistant Infections.

Am J Law Med 2016 05;42(2-3):429-450

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1177/0098858816658275DOI Listing
May 2016

Breakthrough Medical Devices and the 21st Century Cures Act.

Ann Intern Med 2016 Apr 19;164(7):500-2. Epub 2016 Jan 19.

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http://dx.doi.org/10.7326/M15-1906DOI Listing
April 2016

Vaccine Pipeline Has Grown During The Past Two Decades With More Early-Stage Trials From Small And Medium-Size Companies.

Health Aff (Millwood) 2016 Feb;35(2):219-26

Aaron S. Kesselheim is an associate professor of medicine at Harvard Medical School, in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital, in Boston.

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http://dx.doi.org/10.1377/hlthaff.2015.1073DOI Listing
February 2016

Two decades of new drug development for central nervous system disorders.

Nat Rev Drug Discov 2015 Dec 20;14(12):815-6. Epub 2015 Nov 20.

Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts 02120, USA.

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http://dx.doi.org/10.1038/nrd4793DOI Listing
December 2015

Antimicrobial stewardship and public knowledge of antibiotics.

Lancet Infect Dis 2015 Sep;15(9):1000-1001

Division of General Medicine and Primary Care, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

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http://dx.doi.org/10.1016/S1473-3099(15)00235-2DOI Listing
September 2015

Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002-2012.

BMJ Open 2015 Jun 4;5(6):e007987. Epub 2015 Jun 4.

Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, Massachusetts, USA.

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http://dx.doi.org/10.1136/bmjopen-2015-007987DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4458635PMC
June 2015

Accelerating innovation in rapid diagnostics and targeted antibacterials.

Nat Biotechnol 2015 Jun;33(6):589-90

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.

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http://dx.doi.org/10.1038/nbt.3251DOI Listing
June 2015

Precision medicine and the FDA's draft guidance on laboratory-developed tests.

Nat Biotechnol 2015 May;33(5):449-51

Program on Regulation, Therapeutics and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.

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http://dx.doi.org/10.1038/nbt.3221DOI Listing
May 2015

Retinal implants and Medicare reimbursement policies for breakthrough treatments in ophthalmology.

JAMA Ophthalmol 2015 Apr;133(4):373-4

Department of Ophthalmology, Massachusetts Eye and Ear In?rmary, Boston4Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jamaophthalmol.2015.54DOI Listing
April 2015

Surgical applications of 3-dimensional printing and precision medicine.

JAMA Otolaryngol Head Neck Surg 2015 Apr;141(4):305-6

Division of Plastic Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jamaoto.2015.44DOI Listing
April 2015

Paying for innovation: reimbursement incentives for antibiotics.

Sci Transl Med 2015 Feb;7(276):276fs9

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02120, USA.

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http://dx.doi.org/10.1126/scitranslmed.aaa1429DOI Listing
February 2015

AM last page. Survey of MD/MBA programs: opportunities for physician management education.

Acad Med 2015 Jan;90(1):121

Hofstra North Shore Long Island Jewish School of Medicine, Hofstra University Harvard University Harvard University Harvard University primary care physician, Brigham and Women's Hospital and Harvard Business School Department of Health Care Policy, Harvard Medical School, and attending physician, Boston VA Medical Center.

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http://dx.doi.org/10.1097/ACM.0000000000000517DOI Listing
January 2015

New regulatory paradigms for innovative drugs to treat pediatric diseases.

JAMA Pediatr 2014 Oct;168(10):879-80

Division of Emergency Medicine, Boston Children's Hospital, Boston, Massachusetts4Department of Pediatrics, Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jamapediatrics.2014.904DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4741094PMC
October 2014

Global financing and long-term technical assistance for multidrug-resistant tuberculosis: scaling up access to treatment.

PLoS Med 2014 Sep 30;11(9):e1001738. Epub 2014 Sep 30.

Program in Infectious Disease and Social Change, Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, United States of America; Partners in Health, Boston, Massachusetts, United States of America.

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http://dx.doi.org/10.1371/journal.pmed.1001738DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4181959PMC
September 2014

Stock market returns and clinical trial results of investigational compounds: an event study analysis of large biopharmaceutical companies.

Authors:
Thomas J Hwang

PLoS One 2013 7;8(8):e71966. Epub 2013 Aug 7.

Faculty of Arts and Sciences, Harvard University, Cambridge, Massachusetts, United States of America.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0071966PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3737210PMC
August 2014

Association between fluoroquinolone resistance and resistance to other antimicrobial agents among Escherichia coli urinary isolates in the outpatient setting: a national cross-sectional study.

J Antimicrob Chemother 2014 Jun 11;69(6):1720-2. Epub 2014 Feb 11.

Division of Infectious Diseases, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.

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http://dx.doi.org/10.1093/jac/dku029DOI Listing
June 2014

Drug safety in the digital age.

N Engl J Med 2014 Jun;370(26):2460-2

From the Blackstone Group, London (T.J.H.); and the Children's Hospital Informatics Program and the Division of Emergency Medicine, Boston Children's Hospital (F.T.B.), the Department of Pediatrics (F.T.B.) and the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine (J.D.S.), Harvard Medical School, and Brigham and Women's Hospital (J.D.S.) - all in Boston.

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http://dx.doi.org/10.1056/NEJMp1401767DOI Listing
June 2014

Postmarketing trials and pediatric device approvals.

Pediatrics 2014 May 14;133(5):e1197-202. Epub 2014 Apr 14.

Division of Emergency Medicine, Boston Children's Hospital, Boston, Massachusetts; and Department of Pediatrics, Harvard Medical School, Boston, Massachusetts

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http://dx.doi.org/10.1542/peds.2013-3348DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4531281PMC
May 2014

Target small firms for antibiotic innovation.

Science 2014 May;344(6187):967-9

Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02115, USA.

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http://dx.doi.org/10.1126/science.1251419DOI Listing
May 2014

Assessment of US pathway for approving medical devices for rare conditions.

BMJ 2014 Jan 17;348:g217. Epub 2014 Jan 17.

Faculty of Arts and Sciences, Harvard University, Cambridge, MA 02138, USA.

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http://dx.doi.org/10.1136/bmj.g217DOI Listing
January 2014