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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Florida Stores Help Consumers Buy Imported Drugs Despite Federal Ban

Kaiser Health News, June 6, 2016
by Phil Galewitz

LAKELAND, Fla. — A hardy market for imported low-cost prescription drugs has taken root in Fl...

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Florida’s Crackdown On Opioids May Be Influencing Prescribing

Forbes, June 2, 2016
by C.J. Arlotta

Laws crafted to limit the number of opioid prescriptions in Florida seem to be influencin...

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Details On Death Certificates Offer Layers Of Clues To Opioid Epidemic

NPR, June 1, 2016
by Jeff Cohen

[...] There's another reason to get solid data — so you can craft a public health respons...

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Long-Acting Opioid Treatment Could Be Available In A Month

NPR, May 27, 2016
by Martha Bebinger

Labels for the first long-acting opioid addiction treatment device are rolling off printing machine...

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It’s Still Hard to Get Birth Control Pills in California without a Prescription

NPR, May 26, 2016
by Kelly O'Mara

It has been more than 18 months since California's governor signed a law that allows...

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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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Din Erupts Over Obama’s Proposed Medicare Payment Plan

Kaiser Health News, May 23, 2016

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

Patie...

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FDA Considering Pricey Implant As Treatment For Opioid Addiction

NPR, May 20, 2016
by Martha Bebinger

Amid a raging opioid epidemic, many doctors and families in the U.S. have been pleading for better...

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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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Much of World Suffers Not From Abuse of Painkillers, but Absence of Them

New York Times, May 17, 2016
by Rick Gladstone

While Americans are confronting an epidemic of prescription drug abuse, particularly for addic...

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Pharma, The FDA And Social Media

Forbes, May 15, 2016
by Joanna Belbey

The pharmaceutical industry is beginning to embrace more communications and social channels. Accord...

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Pfizer Blocks the Use of Its Drugs in Executions

New York Times, May 13, 2016
by Erik Eckholm

The pharmaceutical giant Pfizer announced on Friday that it has imposed sweeping controls on the di...

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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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China’s Regulators Come Knocking Again At Pharma’s Door

Forbes, May 11, 2016
by Benjamin Shobert

Last week, China’s National Development and Economic Reform Commission (NDRC) announced that...

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Professional ‘Guinea Pigs’ Can Make A Living Testing Drugs

NPR, May 8, 2016
by Rae Ellen Bichell

[...] Like other serial participants in clinical trials, Clough knows that what he's doing...

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Plagued With Out-Of-State Pill Seekers, Missouri Considers Prescription Drug Monitoring

KBIA (NPR Missouri), May 8, 2016
by Bram Sable-Smith

[...] Because it’s the only state that does not yet have a database, Missouri has become...

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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

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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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...

Read More