Michael S Sinha

Michael S Sinha

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Michael S Sinha

Michael S Sinha

Publications by authors named "Michael S Sinha"

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Covid-19 - The Law and Limits of Quarantine.

N Engl J Med 2020 Mar 18. Epub 2020 Mar 18.

From the Center for Health Policy and Law, Northeastern University School of Law (W.E.P., M.S.S.), the Harvard-MIT Center for Regulatory Science (M.S.S.), and Harvard Medical School (M.S.S.) - all in Boston.

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http://dx.doi.org/10.1056/NEJMp2004211DOI Listing
March 2020

FDA and EMA Biosimilar Approvals.

J Gen Intern Med 2019 Dec 2. Epub 2019 Dec 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, USA.

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http://dx.doi.org/10.1007/s11606-019-05408-6DOI Listing
December 2019

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

Correction to: FDA and EMA Biosimilar Approvals.

J Gen Intern Med 2019 Dec 5. Epub 2019 Dec 5.

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/10.1007/s11606-019-05558-7DOI Listing
December 2019

Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem.

Drug Saf 2019 11;42(11):1287-1295

US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.

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http://dx.doi.org/10.1007/s40264-019-00849-8DOI Listing
November 2019

Patients' Knowledge of Key Messaging in Drug Safety Communications for Zolpidem and Eszopiclone: A National Survey.

J Law Med Ethics 2019 Sep;47(3):430-441

Aaron S. Kesselheim, M.D., J.D., M.P.H., is with 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; Michael S. Sinha, M.D., J.D., M.P.H. is with 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; Paula Rausch, Ph.D., R.N., is with the U.S. Food and Drug Administration in Silver Spring, MD; Zhigang Lu, M.D., is with 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; Frazer A. Tessema, B.A., is with 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; Brian M. Lappin, M.A., is with the U.S. Food and Drug Administration in Silver Spring, MD; Esther H. Zhou, M.D., Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Gerald J. Dal Pan, M.D., M.H.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Lee Zwanziger, Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Amy Ramanadham, Pharm.D., M.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Anita Loughlin, Ph.D., is with Optum in Boston, MA; Cheryl Enger, Ph.D., is with Optum in Boston, MA; Jerry Avorn, M.D., is with 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; Eric G. Campbell, Ph.D., is with the Center for Bioethics and Humanities at the University of Colorado in Denver, CO.

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http://dx.doi.org/10.1177/1073110519876176DOI Listing
September 2019

Sexual Harassment in Medicine: Toward Legal Clarity and Institutional Accountability.

EClinicalMedicine 2019 Jan 7;7:3-4. Epub 2019 Feb 7.

Harvard-MIT Center for Regulatory Science, Harvard Medical School, United States of America.

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http://dx.doi.org/10.1016/j.eclinm.2019.01.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6537546PMC
January 2019

Micro-inequities in Medicine.

PM R 2018 10;10(10):1106-1114

Shirley Ryan AbilityLab and Northwestern University, Feinberg School of Medicine, 355 E Erie St, Chicago, IL 60611.

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http://dx.doi.org/10.1016/j.pmrj.2018.08.382DOI Listing
October 2018

The Tax Cuts and Jobs Act of 2017 and the Pharmaceutical Industry.

J Law Med Ethics 2018 09;46(3):806-808

Michael S. Sinha, M.D., J.D., M.P.H., is with the Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmaco-economics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA. Aaron S. Kesselheim, M.D., J.D., M.P.H., is an Associate Professor of Medicine at Harvard Medical School and Director of the Program on Regulation, Therapeutics, and Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at the Brigham and Women's Hospital and a faculty member at the Harvard Center for Bioethics in Boston. He is also a faculty member at the Harvard Center for Bioethics.

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http://dx.doi.org/10.1177/1073110518804246DOI Listing
September 2018

Antitrust, Market Exclusivity, and Transparency in the Pharmaceutical Industry.

JAMA 2018 06;319(22):2271-2272

Rutgers Law School, Rutgers University, Camden, New Jersey.

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http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.20
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http://dx.doi.org/10.1001/jama.2018.3478DOI Listing
June 2018

The next forum for unraveling FDA off-label marketing rules: State and federal legislatures.

PLoS Med 2018 05 8;15(5):e1002564. Epub 2018 May 8.

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, United States of America.

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http://dx.doi.org/10.1371/journal.pmed.1002564DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5940176PMC
May 2018

Expansion of the Priority Review Voucher Program Under the 21 Century Cures Act: Implications for Innovation and Public Health.

Am J Law Med 2018 May;44(2-3):329-341

M.D., J.D., M.P.H., Associate Professor of Medicine, Harvard Medical School and Director, PORTAL, Brigham and Women's Hospital, Boston, MA. The work at PORTAL is supported by the Laura and John Arnold Foundation, with additional support from the Engelberg Foundation and the Harvard Program in Therapeutic Science.

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http://dx.doi.org/10.1177/0098858818789430DOI Listing
May 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

Pharmaceutical Advertising in Medical Journals: Revisiting a Long-Standing Relationship.

Chest 2018 01;153(1):9-11

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/10.1016/j.chest.2017.09.048DOI Listing
January 2018

Determinants of Market Exclusivity for Prescription Drugs in the United States.

JAMA Intern Med 2017 11;177(11):1658-1664

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://dx.doi.org/10.1001/jamainternmed.2017.4329DOI Listing
November 2017

The Effects of the Sunshine Act: What Can and Should We Expect?

Am J Bioeth 2017 Jun;17(6):22-24

a Brigham and Women's Hospital.

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http://dx.doi.org/10.1080/15265161.2017.1316787DOI Listing
June 2017

Regulatory Incentives for Antibiotic Drug Development: A Review of Recent Proposals.

Bioorg Med Chem 2016 12 22;24(24):6446-6451. Epub 2016 Aug 22.

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont St, Suite 3030, Boston, MA 02120, United States. Electronic address:

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http://dx.doi.org/10.1016/j.bmc.2016.08.033DOI Listing
December 2016

The Perils of Panic: Ebola, HIV, and the Intersection of Global Health and Law.

Am J Law Med 2016 05;42(2-3):223-255

JD. Mathews University Distinguished Professor of Law and Professor of Public Policy and Urban Affairs, Northeastern University, Boston, MA, USA.

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http://dx.doi.org/10.1177/0098858816658269DOI Listing
May 2016

Physicians and Insider Trading.

JAMA Intern Med 2015 Dec;175(12):1955-9

Department of Medical Ethics & Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia.

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http://dx.doi.org/10.1001/jamainternmed.2015.5610DOI Listing
December 2015

The impact of tort reform and quality improvements on medical liability claims: a tale of 2 States.

Am J Med Qual 2015 May 14;30(3):263-70. Epub 2014 May 14.

Southern Illinois University School of Medicine, Springfield, IL

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http://dx.doi.org/10.1177/1062860614534460DOI Listing
May 2015

Rousseau at the Roundtable-The Social Contract and the Physician's Responsibility to Society.

Authors:
Michael S Sinha

Virtual Mentor 2011 Oct 1;13(10):703-6. Epub 2011 Oct 1.

Southern Illinois University Schools of Medicine and Law in Springfield.

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http://dx.doi.org/10.1001/virtualmentor.2011.13.10.jdsc1-1110DOI Listing
October 2011

Barking up the wrong tree: the FDA's misguided attempt to waive informed consent in public health emergencies.

Authors:
Michael S Sinha

J Leg Med 2007 Jul-Sep;28(3):397-417

Southern Illinois University, USA.

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http://dx.doi.org/10.1080/01947640701554500DOI Listing
December 2007