Works matching AU Hwang, Thomas J.

Results: 46

Regulatory Review Duration and Differences in Submission Times of Drugs in the United States and Europe, 2011 to 2020.

Published in:

Annals of Internal Medicine, 2023, v. 176, n. 10, p. 1413, doi. 10.7326/M23-0623

By:

Vokinger, Kerstin N.;
Serra-Burriel, Miquel;
Glaus, Camille E.G.;
Rohr, Ulrich-Peter;
Hwang, Thomas J.;
Dalla Torre di Sanguinetto, Simon;
Kesselheim, Aaron S.

Publication type:

Article

Medicaid Expenditures and Estimated Rebates on Line Extension Drugs, 2010-2018.

Published in:

2022

By:

Hwang, Thomas J.;
Feng, Josh;
Maini, Luca;
Kesselheim, Aaron S.

Publication type:

Letter

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

Published in:

Clinical Pharmacology & Therapeutics, 2020, v. 107, n. 3, p. 541, doi. 10.1002/cpt.1669

By:

Neez, Emilie;
Hwang, Thomas J.;
Sahoo, Samali Anova;
Naci, Huseyin

Publication type:

Article

Therapeutic Value of Drugs Frequently Marketed Using Direct-to-Consumer Television Advertising, 2015 to 2021.

Published in:

JAMA Network Open, 2023, v. 6, n. 1, p. e2250991, doi. 10.1001/jamanetworkopen.2022.50991

By:

Patel, Neeraj G.;
Hwang, Thomas J.;
Woloshin, Steven;
Kesselheim, Aaron S.

Publication type:

Article

Therapeutic Value Assessments of Novel Medicines in the US and Europe, 2018-2019.

Published in:

JAMA Network Open, 2022, v. 5, n. 4, p. e226479, doi. 10.1001/jamanetworkopen.2022.6479

By:

Vokinger, Kerstin N.;
Hwang, Thomas J.;
Glaus, Camille E. G.;
Kesselheim, Aaron S.

Publication type:

Article

Public Participation in Drafting of the 21st Century Cures Act.

Published in:

Journal of Law, Medicine & Ethics, 2017, v. 45, n. 2, p. 212, doi. 10.1177/1073110517720650

By:

Hwang, Thomas J.;
Sachs, Rachel E.;
Kesselheim, Aaron S.

Publication type:

Article

Life Cycle of Medical Product Rules Issued by the US Food and Drug Administration.

Published in:

Journal of Health Politics, Policy & Law, 2014, v. 39, n. 4, p. 751, doi. 10.1215/03616878-2743027

By:

Hwang, Thomas J.;
Avorn, Jerry;
Kesselheim, Aaron S.

Publication type:

Article

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

Published in:

2015

By:

Hwang, Thomas J;
Ciolino, Joseph B

Publication type:

journal article

Retinal Implants and Medicare Reimbursement Policies for Breakthrough Treatments in Ophthalmology.

Published in:

JAMA Ophthalmology, 2015, v. 133, n. 4, p. 373, doi. 10.1001/jamaophthalmol.2015.54

By:

Hwang, Thomas J.;
Ciolino, Joseph B.

Publication type:

Article

Global Financing and Long-Term Technical Assistance for Multidrug-Resistant Tuberculosis: Scaling Up Access to Treatment.

Published in:

PLoS Medicine, 2014, v. 11, n. 9, p. 1, doi. 10.1371/journal.pmed.1001738

By:

Hwang, Thomas J.;
Keshavjee, Salmaan

Publication type:

Article

Paying for innovation: Reimbursement incentives for antibiotics.

Published in:

Science Translational Medicine, 2015, v. 7, n. 276, p. 1, doi. 10.1126/scitranslmed.aaa1429

By:

Hwang, Thomas J.;
Carpenter, Daniel;
Kesselheim, Aaron S.

Publication type:

Article

Estimates of Medicaid and Non-Medicaid Net Prices of Top-Selling Brand-name Drugs Incorporating Best Price Rebates, 2015 to 2019.

Published in:

JAMA Health Forum, 2023, v. 4, n. 1, p. e225012, doi. 10.1001/jamahealthforum.2022.5012

By:

Clemans-Cope, Lisa;
Epstein, Marni;
Banthin, Jessica;
Kesselheim, Aaron S.;
Hwang, Thomas J.

Publication type:

Article

Breakthrough Medical Devices and the 21st Century Cures Act.

Published in:

2016

By:

Kesselheim, Aaron S.;
Hwang, Thomas J.

Publication type:

journal article

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

Published in:

International Journal of Cancer, 2019, v. 144, n. 7, p. 1746, doi. 10.1002/ijc.31957

By:

Hwang, Thomas J.;
Gyawali, Bishal

Publication type:

Article

Clinical benefit and cost of breakthrough cancer drugs approved by the US Food and Drug Administration.

Published in:

2020

By:

Molto, Consolación;
Hwang, Thomas J.;
Borrell, Maria;
Andres, Marta;
Gich, Ignasi;
Barnadas, Agustí;
Amir, Eitan;
Kesselheim, Aaron S.;
Tibau, Ariadna

Publication type:

journal article

Factors in Time to Full Approval or Withdrawal for Anticancer Medicines Granted Accelerated Approval by the FDA.

Published in:

JAMA Network Open, 2025, v. 8, n. 3, p. e252026, doi. 10.1001/jamanetworkopen.2025.2026

By:

Tibau, Ariadna;
Hwang, Thomas J.;
Romano, Alejandra;
Borrell, Maria;
Gich, Ignasi;
Molto, Consolacion;
Kesselheim, Aaron S.

Publication type:

Article

Paying for Prescription Drugs in the New Administration.

Published in:

2021

By:

Kesselheim, Aaron S.;
Hwang, Thomas J.;
Avorn, Jerry

Publication type:

journal article

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

Published in:

2019

By:

Hwang, Thomas J.;
Kesselheim, Aaron S.;
Vokinger, Kerstin N.

Publication type:

journal article

Price Increases of Protected-Class Drugs in Medicare Part D, Relative to Inflation, 2012-2017.

Published in:

2019

By:

Hwang, Thomas J.;
Dusetzina, Stacie B.;
Feng, Josh;
Maini, Luca;
Kesselheim, Aaron S.

Publication type:

journal article

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

Published in:

2017

By:

Hwang, Thomas J.;
Darrow, Jonathan J.;
Kesselheim, Aaron S.

Publication type:

journal article

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

Published in:

2017

By:

Hwang, Thomas J.;
Kesselheim, Aaron S.;
Sarpatwari, Ameet

Publication type:

journal article

The Pediatric Research Equity Act Moves Into Adolescence.

Published in:

2017

By:

Bourgeois, Florence T.;
Hwang, Thomas J.

Publication type:

journal article

Coverage of New Drugs in Medicare Part D.

Published in:

Milbank Quarterly, 2022, v. 100, n. 2, p. 562, doi. 10.1111/1468-0009.12565

By:

NACI, HUSEYIN;
KYRIOPOULOS, ILIAS;
FELDMAN, WILLIAM B.;
HWANG, THOMAS J.;
KESSELHEIM, AARON S.;
CHANDRA, AMITABH

Publication type:

Article

Testing of New Drugs Approved From 2015 Through 2021 Under the US Pediatric Research Equity Act.

Published in:

JAMA: Journal of the American Medical Association, 2024, v. 332, n. 17, p. 1482, doi. 10.1001/jama.2024.18338

By:

Liu, Ian T. T.;
Hwang, Thomas J.;
Kesselheim, Aaron S.

Publication type:

Article

Reforming the World Health Organization's Essential Medicines List: Essential but Unaffordable.

Published in:

2022

By:

Hwang, Thomas J.;
Kesselheim, Aaron S.;
Vokinger, Kerstin N.

Publication type:

journal article

New Reforms to Prescription Drug Pricing in the US: Opportunities and Challenges.

Published in:

JAMA: Journal of the American Medical Association, 2022, v. 328, n. 11, p. 1041, doi. 10.1001/jama.2022.15268

By:

Hwang, Thomas J.;
Kesselheim, Aaron S.;
Rome, Benjamin N.

Publication type:

Article

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

Published in:

2016

By:

Hwang, Thomas J.;
Kesselheim, Aaron S.

Publication type:

journal article

Stock Market Returns and Clinical Trial Results of Investigational Compounds: An Event Study Analysis of Large Biopharmaceutical Companies.

Published in:

PLoS ONE, 2013, v. 8, n. 8, p. 1, doi. 10.1371/journal.pone.0071966

By:

Hwang, Thomas J.

Publication type:

Article

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

Published in:

2018

By:

Hwang, Thomas J.;
Tomasi, Paolo A.;
Bourgeois, Florence T.

Publication type:

journal article

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

Published in:

2020

By:

Hwang, Thomas J;
Orenstein, Liat;
DuBois, Steven G;
Janeway, Katherine A;
Bourgeois, Florence T

Publication type:

journal article

New Treatments for Migraine-Therapeutic Ratings and Comparative Coverage in the US, Canada, and Europe.

Published in:

2022

By:

Hwang, Thomas J.;
Vokinger, Kerstin N.;
Kesselheim, Aaron S.

Publication type:

journal article

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

Published in:

2019

By:

Hwang, Thomas J.;
Jain, Nina;
Lauffenburger, Julie C.;
Vokinger, Kerstin N.;
Kesselheim, Aaron S.

Publication type:

journal article

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

Published in:

2016

By:

Hwang, Thomas J.;
Carpenter, Daniel;
Lauffenburger, Julie C.;
Bo Wang;
Franklin, Jessica M.;
Kesselheim, Aaron S.;
Wang, Bo

Publication type:

journal article

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

Published in:

2014

By:

Hwang, Thomas J;
Hooper, David C

Publication type:

Journal Article

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

Published in:

Journal of Antimicrobial Chemotherapy (JAC), 2014, v. 69, n. 6, p. 1720, doi. 10.1093/jac/dku029

By:

Hwang, Thomas J.;
Hooper, David C.

Publication type:

Article

Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US and Europe From 2007 to 2021.

Published in:

JAMA Health Forum, 2022, v. 3, n. 8, p. e222685, doi. 10.1001/jamahealthforum.2022.2685

By:

Vokinger, Kerstin N.;
Kesselheim, Aaron S.;
Glaus, Camille E. G.;
Hwang, Thomas J.

Publication type:

Article

High-risk Therapeutic Devices Approved by the US Food and Drug Administration for Use in Children and Adolescents From 2016 to 2021.

Published in:

JAMA Pediatrics, 2023, v. 177, n. 1, p. 98, doi. 10.1001/jamapediatrics.2022.4131

By:

Pathak, Kavya;
Narang, Claire;
Hwang, Thomas J.;
Espinoza, Juan C.;
Bourgeois, Florence T.

Publication type:

Article

Inclusion of Children in Clinical Trials of Treatments for Coronavirus Disease 2019 (COVID-19).

Published in:

2020

By:

Hwang, Thomas J.;
Randolph, Adrienne G.;
Bourgeois, Florence T.

Publication type:

Opinion

Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act.

Published in:

JAMA Pediatrics, 2019, v. 173, n. 1, p. 68, doi. 10.1001/jamapediatrics.2018.3416

By:

Hwang, Thomas J.;
Orenstein, Liat;
Kesselheim, Aaron S.;
Bourgeois, Florence T.

Publication type:

Article

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

Published in:

JAMA Pediatrics, 2018, v. 172, n. 1, p. 8, doi. 10.1001/jamapediatrics.2017.4012

By:

Bourgeois, Florence T.;
Hwang, Thomas J.

Publication type:

Article

New Regulatory Paradigms for Innovative Drugs to Treat Pediatric Diseases.

Published in:

JAMA Pediatrics, 2014, v. 168, n. 10, p. 879, doi. 10.1001/jamapediatrics.2014.904

By:

Hwang, Thomas J.;
Bourgeois, Florence T.

Publication type:

Article

Surgical Applications of 3-Dimensional Printing and PrecisionMedicine.

Published in:

JAMA Otolaryngology-Head & Neck Surgery, 2015, v. 141, n. 4, p. 305, doi. 10.1001/jamaoto.2015.44

By:

Hwang, Thomas J.;
Kiang, Charlotte;
Paul, Marek

Publication type:

Article

Valuing Patient Satisfaction: A New Paradigm in Medicare Hospital Reimbursement Policy.

Published in:

Harvard Health Policy Review, 2012, v. 13, n. 2, p. 40

By:

Hwang, Thomas J.

Publication type:

Article

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

Published in:

2019

By:

Beall, Reed F.;
Hwang, Thomas J.;
Kesselheim, Aaron S.

Publication type:

Letter

Accelerating innovation in rapid diagnostics and targeted antibacterials.

Published in:

Nature Biotechnology, 2015, v. 33, n. 6, p. 589, doi. 10.1038/nbt.3251

By:

Hwang, Thomas J;
Powers, John H;
Carpenter, Daniel;
Kesselheim, Aaron S

Publication type:

Article

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

Published in:

Nature Biotechnology, 2015, v. 33, n. 5, p. 449, doi. 10.1038/nbt.3221

By:

Hwang, Thomas J;
Lehmann, Lisa Soleymani;
Kesselheim, Aaron S

Publication type:

Article