The Limits to Consumerism in Healthcare:
A lecture by Mary Anne Bobinski

Wednesday, March 02, 2016 12:00 PM
Lectures and Panels
2015-2016
Wasserstein Hall, Room 1010
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

It is often said that health care has moved from paternalism, in the form of “doctor knows be...

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At House Hearing, Pharma Execs Expected To Argue Price Hikes Affect Hospitals, Not Patients

Kaiser Health News, February 4, 2016

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

But M...

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$1 Billion Planned for Cancer ‘Moonshot’

New York Times, February 1, 2016
by Gardiner Harris

WASHINGTON — The Obama administration announced on Monday that it hoped to spend $1 billion t...

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Drug Shortages Forcing Hard Decisions on Rationing Treatments

New York Times, January 29, 2016
by Sheri Fink

[...] In recent years, shortages of all sorts of drugs — anesthetics, painkillers,antibiotics...

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California Pays Insurers Millions More For Hepatitis C Drugs

NPR, January 29, 2016
by Pauline Bartolone

Private health plans invoiced the state of California $387.5 million to cover high-cost hepatitis C...

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California Voters Will Have Their Say On Drug Prices

Kaiser Health News, January 29, 2016
by Anna Gorman

California voters will weigh in this November on a high-stakes ballot proposition intende...

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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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Ed Markey blocks vote on FDA chief over opiate approvals

Boston Globe, January 23, 2016
by Mark Arsenault

US Senator Edward Markey is using Senate rules to block the nomination of a proposed new leader of...

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Pharma ‘cash call’ for new antibiotics

BBC News, January 21, 2016
by James Gallagher

More than 80 pharmaceutical companies have called on governments to develop new ways of paying them...

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Solving Pharma’s Shkreli Problem

Forbes, January 20, 2016
by Matthew Herper

[...] Martin Shkreli has a knack of saying exactly the thing that will make people angry. But the i...

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Ebola: $5m vaccine deal announced

BBC News, January 20, 2016
by James Gallagher

The Vaccine Alliance, Gavi, has signed a $5m (£3.5m) deal for an Ebola vaccine, to protect ag...

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5 Accused of Stealing Drug Secrets From GlaxoSmithKline

New York Times, January 20, 2016
by Katie Thomas

Federal prosecutors in Philadelphia said on Wednesday that they had indicted five people, including...

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France drug trial:

BBC News, January 17, 2016

A man left brain-dead after an experimental drug trial in France has died, local media report.

He...

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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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Giving healthy gay men HIV drugs ‘could help reverse epidemic’ (UK)

BBC News, January 14, 2016
by James Gallagher

Giving daily HIV drugs to healthy gay men has huge potential to help reverse the epidemic, say scie...

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Implant for Opioid Addicts Urged for Federal Approval

New York Times, January 12, 2016
by Sabrina Tavernise

SILVER SPRING, Md. — A panel of medical experts recommended Tuesday that the Food and Dr...

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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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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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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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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!

The...

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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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US big-data health network launches aspirin study

Nature, August 6, 2014
by Sara Reardon, quoting I. Glenn Cohen (Faculty Director)

From the article:

One of the largest big-data experiments in health care has set its first researc...

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US big-data health network launches aspirin study

Nature, August 6, 2014
by Sara Reardon, quoting I. Glenn Cohen (Faculty Director)

From the article:

One of the largest big-data experiments in health care has set its first researc...

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How patent reform’s fraught politics have left USPTO still without a boss

The Washington Post, July 30, 2014
by Nancy Scola, quoting W. Nicholson Price II (Affiliated Faculty)

From the article:

[...] The controversy began in late June when rumors started to trickle out that...

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Clinical Trials and the Right to Remain Silent

JAMA, July 21, 2014
by Michelle Mello, JD, PhD, MPhil and I. Glenn Cohen, JD (Faculty Director)

I. Glenn Cohen has coauthored a new Invited Commentary piece in JAMA on access to clinical trial da...

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Call for Submissions: Journal of Law and the Biosciences

...

Call for Submissions: Journal of Law and the Biosciences

Deadline: Rolling admission.

Journal of Law and the Biosciences (JLB) is actively soliciting original manuscripts, response...

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Supreme Court Decision in Burwell v. Hobby Lobby

by Supreme Court of the United States

Read the Supreme Court's decision in favor of the right of the owners of "closely-held for-prof...

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California Counties Sue 5 Narcotics Makers

Here & Now, NPR, May 22, 2014
by Robin Young interviewing I. Glenn Cohen (Faculty Director)

Two counties in California — Orange and Santa Clara — are suing five major drug compani...

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Public Workshop: Strategies for Responsible Sharing of Clinical Trial Data

Institute of Medicine, National Academies, May 5, 2014
by Featuring a presentation by I. Glenn Cohen (Faculty Director)

Petrie-Flom Center Faculty Director I. Glenn Cohen will participate in a session on "Oper...

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Reforming Brazilian Pharmaceutical Patent Policy:
Lessons from the Past and the Road for the Future

Wednesday, April 23, 2014 12:00 PM
Lectures and Panels
2013-2014
Wasserstein Hall 1010
1585 Massachusetts Ave., Cambridge, MA

In this lecture by Pedro Paranaguá, he discussed the report issued by the Brazilian Hou...

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Dallas Buyers Club:
Free Film Screening and Panel Discussion

Wednesday, April 16, 2014 6:00 PM
Lectures and Panels
2013-2014
Wasserstein Hall 1010
1585 Massachusetts Ave., Cambridge, MA

Students from across Harvard were invited to view a free screening of the Academy-award winning fil...

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Welcome 2014-2016 Academic Fellow Rachel Sachs!

Petrie-Flom Center, April 17, 2014

The Petrie-Flom Center is pleased to announce the new 2014-2016 Academic Fellow, Rachel Sachs. ...

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Make it Work!:

Harvard Law Review 128, 2014
by I. Glenn Cohen (Faculty Co-Director)

This short essay is part of a Harvard Law Review Symposium honoring Justice Breyer on his 20th Year...

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The “Problem” with the European Problem/Solution Approach to Inventive Step

Los Angeles Intellectual Property Law Association, Wegner's Writings, February 24, 2014
by Harold C. Wegner, reviewing Timo Minssen (Petrie-Flom Visiting Scholar)

From the review: Patent applicants seeking to gain global patent protection beyond their home...

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Patents Without Patents:
Regulatory Incentives for Innovation in the Drug Industry

Wednesday, February 19, 2014 12:00 PM
Lectures and Panels
2013-2014
Wasserstein Hall 1015
1585 Massachusetts Ave., Cambridge, MA

Watch Event Recordings

In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing n...

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Patent Trolling:

by Robin Feldman and W. Nicholson Price II (Petrie-Flom Academic Fellow)

Abstract:

Patent trolls — also known variously as non-practicing entities, patent assertion...

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Health Law Year in P/Review

Friday, January 31, 2014 8:30 AM - 5:00 PM
Conferences
2013-2014
Wasserstein Hall, Milstein East B & C
1585 Massachusetts Ave., Cambridge, MA

Watch Event Recordings

Video of this conference is now available at online! (See below for links to specific panels.)

..

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Do Fixed Patent Terms Distort Innovation?:

Public Health Law & Policy e-Journal 5, no. 64, December 4, 2013
by Eric B. Budish, Benjamin N. Roin, and Heidi Williams

Abstract: Patents award innovators a fixed period of market exclusivity, e.g., 20 years in the...

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Health Law Workshop: Aaron Kesselheim

Monday, November 18, 2013 5:00 PM
Health Law Workshops
2013-2014
Hauser 105
1575 Massachusetts Ave., Cambridge, MA

Professor Kesselheim's paper, "Do March-In Rights Protect Public Interests in Medical Products...

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Pharma manufacturing woes dog industry

Chemistry World, October 23, 2013
by Sarah Moulton, quoting W. Nicholson Price II

[...] While many of these problems arise from quality control failures, according to Nicholson...

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Plan B:

Association of Reproductive Health Professionals, Contraception Journal, October 2013
by I. Glenn Cohen, Lisa Sullivan, Eli Y. Adashi

The 8-year legal feud over access to emergency contraception between reproductive health advocates...

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Chris Hansen on “Dis-Owning Nature: The BRCA Gene Patents and the Supreme Court”

Program on Science, Technology, & Society at HKS, November 12, 2013
by Featuring I. Glenn Cohen as a discussant

ABOUT THE SPEAKER

Chris Hansen joined the ACLU in 1973. He spent 10 years at the NYCLU specializin...

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Praise for “Making Do in Making Drugs” by W. Nicholson Price II

Written Description: Patent & IP Blog, Reviewing Recent Scholarship on Patent Law, IP Theory, and Innovation, September 28, 2013
by Camilla Alexandra Hrdy

"'M&M chocolate candies are made with a precision far beyond the capabilities of many drug...

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The Globalization of Health Care
Book Talk and Discussion by Editor I. Glenn Cohen

Tuesday, September 24, 2013 12:00 PM
Lectures and Panels
2013-2014
Wasserstein Hall 3019
1585 Massachusetts Ave., Cambridge, MA
Watch Event Recordings

I. Glenn Cohen, Faculty Co-Director of the Petrie-Flom Center and Professor at Harvard Law School,...

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Making Do in Making Drugs:

Boston College Law Review, forthcoming
by W. Nicholson Price II

Abstract:  

Drug recalls, contamination events, and shortages are on the rise, but drug compa...

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When Truth Cannot Be Presumed:

Boston University Law Review, 2014
by Christopher T. Robertson

Abstract:      
The Food, Drug, and Cosmetic Act (“FDCA”)...

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Issues and Case Studies in Clinical Trial Data Sharing:
What Have We Learned?

Sunday, May 12, 2013
Conferences
2012-2013
Wasserstein Hall, Milstein East, Harvard Law School
1585 Massachusetts Ave., Cambridge, MA
Watch Event Recordings

Objectives:

  • To convene key global stakeholders on a neutral platform to review evidence from rec...
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The Food and Drug Administration in the 21st Century:
The 2013 Petrie-Flom Center Annual Conference

Friday, May 03, 2013 - May 4, 2013
Conferences
2012-2013
Wasserstein Hall, Milstein East ABC, Harvard Law School
Watch Event Recordings

Conference Description

The Food and Drug Administration, the US government’s oldest comprehe...

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Ethical Aspects of Clinical Research in Developing Countries

The European Group on Ethics in Science and New Technologies, 2003

This guidance document places particular emphasis on the ethical issues surrounding pharmaceutical...

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