CALL FOR ABSTRACTS: 2017 Annual Conference
Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits

Friday, April 28, 2017
Conferences
2016-2017
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is...

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Health Care after the Election

Monday, October 24, 2016 12:00 PM
Lectures and Panels
2016-2017
Room TBD
Harvard Law School, Cambridge, MA

Description:

As we approach the 2016 presidential election and change of administration, there are...

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Health Law Workshop: W. Nicholson Price II

Monday, October 17, 2016 5:00 PM
Health Law Workshops
2016-2017
Room TBD
Harvard Law School, Cambridge, MA

Nicholson Price is an Assistant Professor at the University of Michigan School of Law, where h...

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As Opioid Epidemic Surges, Medical Schools Try To Keep Pace

NPR, July 27, 2016
by Natalie Jacewicz

[...] Americans are overdosing on opioids such as heroin and prescribed painkillers...

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Montana’s ‘Pain Refugees’ Leave State To Get Prescribed Opioids

NPR, July 20, 2016
by Corin Cates-Carney

Federal authorities say about 78 Americans die every day from opioid overdose. In Montana, health c...

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Generic Crestor Wins Approval, Dealing a Blow to AstraZeneca

New York Times, July 20, 2016
by Andrew Pollack

The Food and Drug Administration said Wednesday that it had approved generic versions of...

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Drugmakers Deploy New Patents To Delay Generic Versions Of Humira And Enbrel

Kaiser Health News, July 18, 2016

KHN Morning Briefing: Summaries of health policy coverage from major news organizations

In ot...

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Reefer Madness! Medical Marijuana Is Already Saving $165M Per Year For Medicare

Forbes, July 18, 2016
by Steven Salzberg

[...] A new study in the journal Health Affairs looked in great detail at presc...

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Senate Approves Bill to Combat Opioid Addiction Crisis

New York Times, July 13, 2016
by Emmarie Huetteman

WASHINGTON — The Senate on Wednesday approved a bill to tackle the nation’s opioid cris...

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Lower-cost biotech drug gets thumbs up from FDA panel

Washington Post, July 12, 2016
by Matthew Perrone, AP

WASHINGTON — The second-biggest selling drug in the world could get some cheaper competition...

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Consumer Group:

Kaiser Health News, July 11, 2016

KHN Morning Briefing: Summaries of health policy coverage from major news organizations

Publi...

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A Trojan Horse?

Ohio State Law Journal, 2017 (forthcoming)
by Christopher T. Robertson (Academic Fellow alumnus)

Abstract:      
Scholars, advocates, and courts have begun to recogni...

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Nudging Health: Health Law and Behavioral Economics:

Johns Hopkins University Press, October 2016 (forthcoming)
by I. Glenn Cohen (Faculty Director), Holly Fernandez Lynch (Executive Director), and Christopher T. Robertson (Academic Fellow alumnus), eds.

Pre-order the book here!

Abstract of the Introduction: 

This introductory chapter to th...

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After Medical Marijuana Legalized, Medicare Prescriptions Drop For Many Drugs

NPR, July 6, 2016
by Shefali Luthra

Prescription drug prices continue to climb, putting the pinch on consumers. Some older Americans ap...

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Obama Administration Eases Restrictions On Doctors Who Treat Opioid Addiction

NPR, July 6, 2016
by Alison Kodjak

The Obama administration is making it easier for people addicted to opioids to get treatment.

Heal...

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Biden threatens funding cuts for researchers who fail to report clinical trial results

Stat, June 29, 2016
by David Nather and Charles Piller

WASHINGTON — At a national cancer summit Wednesday, Vice President Joe Biden t...

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Latest Plan to Cut Medicare Drug Payments Leaves Senators Skeptical

New York Times, June 28, 2016
by Robert Pear

WASHINGTON — Under fire from senators in both parties, a senior federal health official told...

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An N.Y.U. Study Gone Wrong, and a Top Researcher Dismissed

New York Times, June 27, 2016
by Benedict Carey

New York University’s medical school has quietly shut down eight studies at its prominent psy...

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Brexit Won’t Change Britain’s Drug Regulatory Scheme

Forbes, June 27, 2016
by Scott Gottlieb

The Brexit has sent quivers through the ranks of the pharmaceutical industry. There are f...

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New Ways to Treat Pain Meet Resistance

New York Times, June 22, 2016
by Barry Meier and Abby Goodnough

[...] Mr. Scott’s story highlights one patient’s success. Yet it also underscores the d...

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Birth Control via App Finds Footing Under Political Radar

New York Times, June 19, 2016
by Pam Belluck

A quiet shift is taking place in how women obtain birth control. A growing assortment of new a...

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Despite Overdose Epidemic, Georgia Caps The Number Of Opioid Treatment Clinics

NPR, June 15, 2016
by Michelle Eloy

[...] Outpatient clinics like the one Talbott co-owns dispense drugs like methadone and bupren...

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Drug Maker’s Former Employees Accused of Shady Dealings With Doctors

New York Times, June 10, 2016
by Katie Thomas

[...] Mr. Roper and a former sales representative, Fernando Serrano, were arrested on Thursday...

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Investors See Big Opportunities In Opioid Addiction Treatment

NPR, June 10, 2016
by Alison Kodjak

[...] Every crisis presents an opportunity, as the saying goes. And when it comes to opioid ad...

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FDA Takes Action Against Websites Illegally Selling Unapproved Prescription Drug Products

Forbes, June 9, 2016
by C. J. Arlotta

Criminals profiting from consumers purchasing unapproved prescriptions drugs off the Internet are b...

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Health Insurance as Innovation Incentive

Jotwell, June 9, 2016
by Amy Monahan, reviewing paper by Rachel E. Sachs (Academic Fellow)

Excerpt from the article:

In Prizing Insurance: Prescription Drug Insurance as Innovation Incentiv...

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In Texas, Strict Laws On Clinics Drive Demand For Abortion Pill

NPR, June 8, 2016
by John Burnett

The abortion pill is booming in Texas. Since the FDA loosened restrictions, more women are circumve...

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FDA Moves To Speed Access To Compassionate-Use Drugs

NPR, June 8, 2016
by Rachel Bluth

The Food and Drug Administration has reduced an obstacle from its compassionate use policy, streaml...

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New Opioid Limits Challenge the Most Pain-Prone

New York Times, June 6, 2016
by Paula Span

If you’ve come to rely on opioids for chronic pain, as a growing proportion of older adults h...

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The Relationship Between Bioethics and U.S. Health Law:

In The Oxford Handbook of U.S. Healthcare Law, I. Glenn Cohen, Allison K. Hoffman, and William M. Sage, eds., May 2016
by I. Glenn Cohen (Faculty Director)

Abstract: This chapter explores the way bioethics is taught as part of U.S. health law. It beg...

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FDA’s Punt on Finalizing the Generic Drug Labeling Rule: Experts Debate

Regulatory Affairs Professionals Society, May 19, 2016
by Zachary Brennan, featuring Rachel E. Sachs (Academic Fellow)

From the article: 

Rachel Sachs, JD, an academic fellow at the Petrie-Flom Center for Health...

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Divided Infringement and the Doctor-Patient Relationship

IP Theory, 2016 (Forthcoming)
by Rachel E. Sachs (Academic Fellow)

Abstract:      
With its recent en banc decision in Akamai v. Limelig...

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Resolving Reverse-Payment Settlements with the Smoking Gun of Stock Price Movements

81 Iowa Law Review 1581, 2016
by Thomas G. McGuire, Keith Drake, Einer Elhauge (Founding Faculty Director), Raymond S. Hartman, Martha Starr

Abstract: The Supreme Court recently held that in reverse-payment settlements of drug patent d...

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What’s next for opioid legislation?

Politico Pulse, April 22, 2016
by Dan Diamond, referencing Rachel E. Sachs (Academic Fellow)

Excerpt from article:

[...] HEALTH WONK RECAP — PULSE flagged a few interesting st...

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Prizing Insurance: Prescription Drug Insurance as Innovation Incentive,

Harvard Journal of Law and Technology, Vol. 30, No. 1 (forthcoming)
by Rachel E. Sachs

Abstract: 

A problem perennially facing scholars of both intellectual property and health law...

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Promoting Healthcare Innovation on the Demand Side,

U of Michigan Law & Econ Research Paper No. 16-008; U of Michigan Public Law Research Paper No. 503
by Rebecca Eisenberg and W. Nicholson Price II (Academic Fellow Alumnus)

Abstract:

Innovation policy often focuses on the incentives of firms that sell new products. But o...

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Harvard Medical School’s 2016 Bioethics Conference:
Social Justice and Ethics Committees in Health Care: Core to our Mission or None of our Business?

Thursday, April 14, 2016 8:00 AM - 6:00 PM
Conferences
2015-2016
Joseph B. Martin Conference Center, Harvard Medical School
77 Avenue Louis Pasteur, Boston, MA

Couldn't make it to the conference? Join the conversation on Twitter using #HMSABC!

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Chinese Market Offers New Life to Many Drugs

Dow Jones Business News, March 29, 2016
by Fanfan Wang, quoting I. Glenn Cohen (Faculty Director)

Excerpt from Article:

[...] But the new trend also raises the question of whether China has become...

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Ethicist

...

Ethicist
Trillium Health Partners

Deadline: March 08, 2016

Position: Ethicist

Status: Full Time

File#: 2016-4494

Dept/Health System: Ethics

Site: Trillium...

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Fecal Transplants to Treat C. difficile: FDA Seeks Comment on What IND Requirements to Waive

Regulatory Affairs, February 29, 2016
by Zachary Brennan, citing Rachel E. Sachs (Academic Fellow)

From the article: 

[...] The draft guidance comes as over the past few years, FMT, which basi...

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Negotiating for Health:
The Role of Negotiation and Dispute Resolution in Healthcare

Saturday, February 27, 2016 9:00 AM - 4:30 PM
Conferences
2015-2016
Austin Hall, North Classroom
Harvard Law School, Cambridge, MA

Harvard Negotiation Law Review Presents its 21st Annual Symposium

Agenda Overview

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New Journal of Law & Biosciences featuring Harvard student work

Journal of Law and the Biosciences (JLB), Vol. 3, Issue 1 (April 2016)

The Journal of Law and the Biosciences, the open-access journal launched in 2014 by the P...

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How to Make the Most of Drugs We Already Have

The Upshot, New York Times, February 22, 2016
by By Austin Frakt, citing Ben Roin (Academic Fellow alumnus)

From the article

[...] Moreover, if a drug company cannot ascertain the problem for which a prescr...

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Fourth Annual Health Law Year in P/Review

Friday, January 29, 2016 8:00 AM - 5:00 PM
Conferences
2015-2016
Wasserstein Hall, Milstein West AB
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Couldn't attend in person? Learn more about the event:

  • Learn more about the presentations...

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Does it break the law to charge a lot for a cure?

The Incidental Economist Blog, January 28, 2016
by Nicolas Bagley, quoting Rachel E. Sachs (Academic Fellow)

From the article:

[...] Talk about sending the wrong signals about what sorts of drugs we value mo...

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“FDA in the 21st Century: A Panel Discussion”:

MAGI, May 2, 2016, 8:30 - 10:00 AM
by Holly Fernandez Lynch (Executive Director) and I. Glenn Cohen (Faculty Director)

On Monday, May 2, 2016, from 8:30 to 10:00am, Petrie-Flom Executive Director Holly Fernandez Lynch...

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Why Preventing Cancer Is Not the Priority in Drug Development

The Upshot, New York Times, December 28, 2015
by Austin Frakt, citing Ben Roin (former Academic Fellow and Faculty Co-Director)

From the article: 

Most people would agree that it would be better to prevent cancer, if...

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How to Decrease Prices for an Expensive Class of Drugs

The New York Times, November 16, 2015
by Austin Frakt, quoting W. Nicholson Price II (Academic Fellow Alumnus)

Excerpt from the article:

[...] As the law professors W. Nicholson Price and Arti Rai put it,...

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Second Annual HLS-UCLA Food Law and Policy Conference:
Drugs, Animals, and Food: Law & Policy of Antibiotics in the Food System

Friday, October 23, 2015 8:30 AM - 3:30 PM
Conferences
2015-2016
Pound Hall, Room 102
Harvard Law School, 1536 Massachusetts Ave., Cambridge, MA

Description

The debate over antibiotic use in animal agriculture combines elements of science, eth...

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Regulating Secrecy

Washington Law Review, 2015 (Forthcoming)
by W. Nicholson Price II (Academic Fellow Alumnus)

Abstract:      


Regulation interacts with intellectual-property exc...

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Salad Days: Professor Jacob Gersen on the rise of food law

Harvard Crimson, September 29, 2015
by Michael Zuckerman, quoting Jacob Gersen (Director, Food Law Lab at the Petrie-Flom Center& Affiliated Faculty)

From the article:

[...] Much of Harvard Law School now seems hungry to talk about it, too. In addi...

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Heidi Williams wins MacArthur “genius grant”

MIT News, September 29, 2015
by Peter Dizikes, on Heidi Williams (Student Fellow Alumna)

From the article:

MIT economist Heidi Williams, whose scholarly work looks at the effects of paten...

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How Patent Law Can Block Even Lifesaving Drugs

New York Times, September 28, 2015
by Austin Frakt, quoting Benjamin Roin (Former Faculty Co-Director & Academic Fellow; Current Affiliated Faculty)

From the article:

To see evidence of this, just look at the behavior of pharmaceutical firms. When...

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How Prescription Drugs Get So Wildly Expensive

WIRED, September 23, 2015
by Nick Stockton, quoting Rachel E. Sachs (Academic Fellow)

From the article:

[...] With all that in mind, here’s the important question: Is S...

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FDA in the 21st Century:

Columbia University Press, September 2015
by Holly Fernandez Lynch (Executive Director) and I. Glenn Cohen (Faculty Director), eds.

Just out from Columbia University Press, FDA in the Twenty-First Century: The Challenges...

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Review of Human Subjects Research Regulation: Perspectives on the Future

IRB: Ethics & Human Research, July-August 2015, Vol. 37, No. 4
by Christine Grady

Christine Grady, MSN, PhD, the chief of the Department of Bioethics in the Clinical Center of the N...

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Will clinical trial data disclosure reduce incentives to develop new uses of drugs?

Nature Biotechnology, July 2015, Vol. 33, No. 7
by W Nicholson Price II (Academic Fellow alumnus) & Timo Minssen (past Visiting Scholar)

Petrie-Flom Academic Fellow alumnus Nicholson Price, now an Assistant Professor at the&nb...

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More than meets the IRB: On human subjects research and regulation: perspectives on the future

More Than Meets the IRB Podcast , May 2015, No. 11
by Holly F. Lynch (Executive Director), I. Glenn Cohen (Faculty Director), Michael Leary

In this eleventh installment of “More Than Meets the IRB,” we talk with I. Glenn Cohen...

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Countdown to Cures

The Medicine Maker, June 25th, 2015, Issue #0615
by Stephanie Sutton, quoting Rachel Sachs (Academic Fellow)

From the article: 

[...] According to Rachel Sachs, an academic fellow at the Petrie-Flom Cen...

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Fall 2015 Course: Drug Product Liability Litigation

...

Fall 2015 Course: Drug Product Liability Litigation
Harvard Law School

Deadline: Waitlist processing will run from Monday, May 18, 2015 through Friday, June 26, 2015.

Drug Product Liability Litigation

Mr. Peter Grossi
Fall 2015 Course
Meets: T, W 5:00pm - 7:00..
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“Ending Institutional Corruption” conference, May 1-2

Edmond J. Safra Center for Ethics at Harvard University, April 14, 2015

On Friday, May 1, and Saturday, May 2, several Petrie-Flom Center affiliates will participate in th...

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Health Law Workshop: Rachel E. Sachs

Monday, April 13, 2015 5:00 PM
Health Law Workshops
2014-2015
Griswold Hall, Room 110
1525 Massachusetts Ave., Cambridge, MA

Presentation Title: "Rethinking the Incentives/Access Dichotomy: Prescription Drug Reimbursement as...

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Resolving Reverse-Payment Settlements with the Smoking Gun of Stock Price Movements

Iowa Law Review, Vol. 81, No. 4, 2016 Forthcoming
by Thomas G. McGuire, Keith Drake, Einer Elhauge (Founding Faculty Director), Raymond S. Hartman, Martha Starr

Founding Faculty Director Einer Elhauge and four co-authors have just posted a new article&nbs...

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Are trade secrets delaying biosimilars?

Science, April 10, 2015
by W. Nicholson Price II (Academic Fellow Alumnus) and Arti K. Rai

Petrie-Flom Academic Fellow alumnus Nicholson Price, now an Assistant Professor at the Un...

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FDA’s Impact on Pharmaceutical Innovation:
A lecture by Neil Flanzraich

Thursday, April 09, 2015 12:00 PM
Lectures and Panels
2014-2015
Griswold Hall, 110
Harvard Law School, 1525 Massachusetts Ave., Cambridge, MA

Neil Flanzraich, Chairman and CEO of Cantex Pharmaceuticals, Inc., discussed the balance between sp...

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Robust Exclusion and Market Division Through Loyalty Discounts

Harvard Public Law Working Paper No. 14-12, April 2, 2015
by By Einer Elhauge (Founding Faculty Director) and Abe Wickelgren

Founding Faculty Director Einer Elhauge has coauthored an article Abe Wickelgren on loyalty discoun...

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Clinical Trial Recruitment: Problems, Misconceptions, and Possible Solutions,

Petrie-Flom Center, February 5, 2015

On January 19 - 21, 2015, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethic...

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Third Annual Health Law Year in P/Review

Friday, January 30, 2015 7:45 AM - 5:00 PM
Conferences
2014-2015
Wasserstein Hall, Milstein East AB
1585 Massachusetts Avenue, Cambridge, MA

Couldn't make it in person? Check out the individual sessions in the videos linked above and&nb...

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Program Manager

...

Program Manager
Harvard Multi-Regional Clinical Trials Center

Deadline: Open until filled.

The mission of the MRCT Center at Harvard is to improve the design, conduct, and oversight of multi...

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First biosimilar drug set to enter US market:

Nature, January 13, 2015
by Heidi Ledford, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] The FDA is expected to make a final decision by May. But even as Sandoz prepares to sell its...

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Houston doctor sued for trading prescriptions for sex

Houston Chronicle, December 12, 2014
by St. John Barned-Smith, quoting I. Glenn Cohen (Faculty Director)

[...] Legal experts who specialize in medical ethics said the allegations and actions captured on f...

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Emerging Issues and New Frontiers for FDA Regulation

Monday, October 20, 2014 8:00 AM - 5:00 PM
Conferences
2014-2015
Washington, DC

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law...

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​Nudging the FDA

The American Interest, October 17, 2014
by W. Nicholson Price II (Academic Fellow alumnus) and I. Glenn Cohen (Faculty Director)

From the article:

[...] The FDA’s regulation of drugs is frequently the subject of poli...

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Can Big Data Cure Cancer?

U.S. News, October 15, 2014
by Lindsey Cook, quoting I. Glenn Cohen (Faculty Director)

From the article: 

In some ways, the learning health system has been around since the beginni...

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Post-Trial Responsibilities:
Ethics and Implementation

Thursday, September 18, 2014 7:30 AM - 5:30 PM
Conferences
2014-2015
Wasserstein Hall, Milstein East AB
1585 Massachusetts Ave., Cambridge, MA

Conference Description 

Who:

Clinical research sponsors, investigators, funders, regulators...

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An Interview with I. Glenn Cohen on Controversial Health Issues

PBS.org, September 9, 2014
by Tavis Smiley, interviewing I. Glenn Cohen (Faculty Director)

In an interview with PBS.org, Faculty Director I. Glenn Cohen, sat down with Tavis Smiley to d...

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Ebola Crisis and Rationing

CCTV Mandarin, August 13, 2014
by CCTV Broadcaster, interviewing I. Glenn Cohen (Faculty Director)

Faculty Director I. Glenn Cohen appeared on CCTV Mandarin to discuss the ration...

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