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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Hearing Aid Prices Under Pressure From Consumer Electronics

New York Times, April 20, 2016
by Andrew Pollack

[...] The consumer electronics industry is encroaching on the hearing aid business, offering p...

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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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Justice Department, SEC Launch Probes Into Theranos’ Practices And Technology

Kaiser Health News, April 19, 2016

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

The i...

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The Female Viagra, Undone by a Drug Maker’s Dysfunction

New York Times, April 9, 2016
by Katie Thomas and Gretchen Morgenson

Last August, Sprout Pharmaceuticals had a new pill on its hands that quickly captured the nation&rs...

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Book Review: FDA in the Twenty-First Century:The Challenges of Regulating Drugs and New Technologies

Journal of Law and the Biosciences, Vol. 3, Issue 1 (April 1, 2016)
by Ryan Abbot, reviewing book edited by Holly Fernandez Lynch (Executive Director) and I. Glenn Cohen (Faculty Director)

From the review: 

FDA in the 21st Century is an excellent edited volume based on th...

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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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Feeling Better: What is the FDA doing, and how is it doing it?

The Weekly Standard, March 21, 2016
by by Devorah Goldman, reviewing FDA in the 21st Century by Holly F. Lynch (Executive Director) and I. Glenn Cohen (Faculty Director)

Excerpt from the article:

[...] In his last State of the Union address, Barack Obama asked, &...

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A Tool to Help Address Key Ethical Issues in Research

Journal of Medical Ethics Blog, February 22, 2016
by Rebecca H. Li & Holly Fernandez Lynch (Executive Director)

From the article: 

One of the most important responsibilities of a clinical project lead at a...

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FDA - Food

U.S. Food and Drug Administration

Website for the U.S. Food and Drug Administration, one of the agencies responsible for regulating t...

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Title 21: Food and Drugs

Code of Federal Regulations

In Chapter I, Subchapter B, Parts 100-190, the regulations applicable to FDA’s oversight of f...

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FDA - Guidance and Regulation

U.S. Food and Drug Administration

Section of the FDA website containing FDA guidance and regulatory information applicable to food, i...

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Planned Parenthood And Fetal Tissue Sale: Manufactured Controversy And The Real Ethical Debate

Health Affairs Blog, March 9, 2016
by I. Glenn Cohen (Faculty Director)

From the article:

[...] Planned Parenthood received US $528 million of government money...

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Food Code

U.S. Food and Drug Administration

The FDA’s Food Code is a model that assists food control jurisdictions at all levels of gover...

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USDA - Food Safety

U.S. Department of Agriculture, Food Safety and Inspection Service

Website for FSIS, an agency of the USDA responsible for ensuring food safety for meat, poultry, and...

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Foodborne Outbreaks

Centers for Disease Control

This site outlines the CDC’s role in investigation, surveillance, and prevention of food safe...

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Food Safety

FoodSafety.gov

Describes provisions of the Food Safety Modernization Act of 2011 and their role in strengthening t...

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Codex Alimentarius

World Health Organization

The Codex, administered by WHO and the U.N. Food and Agriculture Organization, establishes internat...

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Food Labeling Litigation

by Nicole E. Negowetti

Report on food labeling class action lawsuits and FDA regulatory authority. 

... Read More

Food and Drug Law Institute

Non-profit site providing a space for discussion of food and drug law, including conferences and pu...

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Harvard Food Law and Policy Clinic

The Harvard Law School clinic focused on seeking to increase access to healthy foods, reduce food w...

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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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Food Safety News

Website providing coverage on food safety issues, including contributions from the FDA.

... Read More

The Unpatentable Microbiome

New England Regional Junior Faculty Scholarship Workshop, February 12, 2016
by Rachel E. Sachs (Academic Fellow)

Presentation Abstract: 

Scientists have recently begun to appreciate the important role playe...

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Food and Drug Law

Peter Hutt et al., 2013

Introductory casebook on administrative and other key issues in food and drug law. 

... Read More

Expert Committee: FDA Should Allow Mitochondrial Replacement Trials Under Certain Conditions

Regulatory Affairs, February 3, 2016
by Zachary Brennan, quoting I. Glenn Cohen (Faculty Director)

From the article:

Glenn Cohen, faculty director of the Petrie-Flom Center for Health Law Policy, B...

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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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“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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FDA Says Gay Men Can Give Blood — But Only If They Don’t Have Sex for a Year

VICE News, December 22, 2015
by VICE News Staff, quoting I. Glenn Cohen (Faculty Director)

From the article:

[...] Harvard Law School bioethics and the law professor I. Glenn Cohen told VIC...

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FDA eases blood donation ban on gay men

CBS News, December 21, 2015
by Interview with I. Glenn Cohen (Faculty Director)

The FDA is easing its restrictions on gay and bisexual men who want to make a blood donation. But t...

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FDA’s Pathway for Regulation of Fecal Microbiota Transplants

Journal of Law and the Biosciences, October 26, 2015
by Margaret F. Riley and Bernat Olle, in response to Rachel Sachs (Academic Fellow)

From the article: 

[...] A recent article by Rachel Sachs and Carolyn Edelstein inthe Journal...

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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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Neuroethics Seminar: Brain Hacking to Boost Your A-Game:
The Ethics of Cognitive Enhancement in Gaming and Competition

Wednesday, October 21, 2015 4:30 - 6:00 PM
Lectures and Panels
2015-2016
Armenise Building, D Amphitheatre
Harvard Medical School, 210 Longwood Ave., Boston, MA

Event Description

This event was free and open to the public. 

Personal enhancement isn'...

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Blood Illuminated: Panel Discussion of FDA Blood Ban From Gay and Bisexual Men

YouTube Video of Event at Katzen Arts Center, American University, October 6, 2015
by I. Glenn Cohen (Faculty Director)

From a description of the event on Out Magazine:

Dating back to a policy enacted during the height...

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Innovations in Health Law and Policy: Regulatory Challenges and Strategies for Change Conference

UNH School of Law, October 26, 2015
by W. Nicholson Price II (Academic Fellow Alumnus)

Innovations in Health Law and Policy: Regulatory Challenges and Strategies for Change

When: Monday...

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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 Innovation Law and Policy: Preserving the Future of Personalized Medicine

Written Description Blog, July 27, 2015
by Lisa Ouellette

From the review:

I highly recommend two recently posted articles on declining innovation incentive...

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Research, Regulation, and Ethics: Discussion of Human Subjects Research Regulation Book

Science for the People Podcast, July 2015, No. 327
by Desiree Schell

About the podcast:

This week we're learning about the regulatory frameworks that try to balanc...

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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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PAPER NOW AVAILABLE:

Journal of Law & the Biosciences, July 6, 2015 (Published Online)
by Rachel Sachs (Academic Fellow) and Carolyn Edelstein

Academic Fellow Rachel E. Sachs has a new article on the regulatory challenges ...

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Food Law and Policy Clinical Fellow

...

Food Law and Policy Clinical Fellow
Harvard Food Law and Policy Clinic

Deadline: Open until filled.

The Harvard Food Law and Policy Clinic, a division of the Center for Health Law and Policy Innovati...

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Faculty Director I. Glenn Cohen: New Blood-Donor Policy, Same Gay Stigma

New York Times, May 21, 2015
by I. Glenn Cohen (Faculty Director) and Eli Y. Adashi

Faculty Director I. Glenn Cohen has co-authored an op-ed for the New York Times on the FD...

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Drug Product Liability Litigation Course

...

Drug Product Liability Litigation Course
Harvard Law School

Deadline: Open until filled.

Instructor: Mr. Peter Grossi

Semester: Fall 2015 Course

Meets: T, W 5:00pm - 7:00p.

.. Read More

Innovation Law and Policy:

U. C. Davis Law Review, Forthcoming 2016
by Rachel E. Sachs

Academic Fellow Rachel E. Sachs has a new article forthcoming in 2016 on law and the future of pers...

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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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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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Transatlantic Lessons in Regulation of Mitochondrial Replacement Therapy:

Science, April 10, 2015
by I. Glenn Cohen (Faculty Director), with Eli Adashi and Julian Savulescu

Cambridge, Mass., April 9, 2015 – A paper forthcoming on Friday in Science discusses the regu...

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Trio contrast approaches taken by Britain versus the US concerning mitochondrial replacement therapy

MedicalXpress, April 10, 2015
by Bob Yirka, citing I. Glenn Cohen (Faculty Director) et al.

Glenn Cohen, with Harvard University, Julian Savulescu, with the University of Oxford and Eli Adash...

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Is UK evaluation of reproductive tech a model for US?

MedicalXpress, April 10, 2015
by David Orenstein, citing I. Glenn Cohen (Faculty Director) et al.

When the United Kingdom resoundingly approved mitochondrial replacement therapy in Februa...

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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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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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A “Natural” Experiment:
Consumer Confusion and Food Claims, a lecture by Efthimios Parasidis

Thursday, January 29, 2015 12:00 PM
Lectures and Panels
2014-2015
Wasserstein Hall, Milstein West B
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Video of the lecture and following discussion is available online.

What makes food "natural"? Do c...

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Outbreak: Developing New Medical Products for Epidemics,
A lecture by Peter Hutt

Thursday, January 15, 2015 12:30 PM
Lectures and Panels
2014-2015
Hauser Hall 102
1575 Massachusetts Avenue, Cambridge, MA

Video of the lecture and following discussion are available online.

The recent outbreak of Ebola h...

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Research Project Grant Funding Opportunity

...

Research Project Grant Funding Opportunity
National Institutes of Health (NIH)

Deadline: January 19, 2015

Funding Opportunity Title: Empirical Research on Ethical Issues Related to Central IRBs and Co...

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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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FDA plans to end prohibition on blood donation by gay men, with conditions

PBS News Hour, December 23, 2014
by Gwen Ifill, interviewing I. Glenn Cohen (Faculty Director)

"[...] the ban that we had in place was really outdated. It dates back to 1983, the early days of t...

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F.D.A. Easing Ban on Gays, to Let Some Give Blood

New York Times, December 23, 2014
by Sabrina Tavernise, quoting I. Glenn Cohen (Faculty Director)

[...] “This is a major victory for gay civil rights,” said I. Glenn Cohen, a law profes...

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FDA Announces Plans to End Lifetime Ban on Gay Men Donating Blood

Vice News, December 23, 2014
by Colleen Curry, quoting I. Glenn Cohen (Faculty Director)

[...] Harvard Law School bioethics and the law professor I. Glenn Cohen told VICE News that while h...

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US lifts ban on gay men donating blood — as long as they don’t have sex with other men

Vox, December 23, 2014
by Sarah Kliff and Julia Belluz, quoting I. Glenn Cohen (Faculty Director)

[...] Glenn Cohen, a Harvard Law professor who wrote about the blood donor rule in JAMA: the J...

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Reconsideration of the Lifetime Ban on Blood Donation by Men Who Have Sex With Men

JAMA, July 23, 2014
by I. Glenn Cohen, JD (Faculty Director); Jeremy Feigenbaum, JD; Eli Y. Adashi, MD, MS

Faculty Director I. Glenn Cohen has co-authored a new Viewpoint piece in the July 23/30, 2014 issue...

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FDA Advisors Not Sold on Lifting Ban on Gay Men Giving Blood

Philly.com, December 3, 2014
by Dennis Thomson, quoting I. Glenn Cohen (Faculty Director)

[...] The FDA first adopted the policy at the dawn of the AIDS crisis. However, changing times and...

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Decades-old ban on blood donations from gay men to be revisited

MSNBC, December 1, 2014
by Andrea Mitchell interviewing I. Glenn Cohen (Faculty Director)

Petrie-Flom Faculty Director I. Glenn Cohen, who co-wrote the argument against the ban on gay...

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Will FDA Lift Gay Blood Donor Ban?

NewsMax Health, December 1, 2014
by Quoting I. Glenn Cohen (Faculty Director)

[...] "They really are out of step with the rest of the world," Glenn Cohen, a Harvard Law School p...

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US FDA to Consider Lifting Ban on Gay Men Donating Blood:

International Business Times, November 30, 2014
by Hannah Osborne, quoting I. Glenn Cohen (Faculty Director)

[...] Speaking of the forthcoming discussion, Glenn Cohen, a medical ethics professor at Harva...

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Government could ease 31-year-old ban on blood donations from gay men

Washington Post, November 29, 2014
by Brady Dennis, quoting I. Glenn Cohen (Faculty Director)

[...] “They really are out of step with the rest of the world,” said Glenn Cohen, a Har...

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FDA weighs lifting ban on blood donations from gay men

The Hill, November 28, 2014
by Sarah Ferris, quoting I. Glenn Cohen (Faculty Director)

[...] “The public health rationale for this ban has kind of been packed away,” said Gle...

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The Changing Regulation of Laboratory-Developed Tests:

Genomic Medicine Case Conference (GMCC) at Massachusetts General Hospital, November 14, 2014
by Rachel Sachs (Academic Fellow)

On November 14, 2014, Academic Fellow Rachel Sachs delivered a talk on the topic of the FDA&rs...

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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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Newsmax Panel: Experimental Ebola Drugs Have Run Out

Newsmax TV, October 6, 2014
by America's Forum, interviewing I. Glenn Cohen (Faculty Director)

From the article:

[...] The Liberian man diagnosed with Ebola in Dallas is not receiving an experi...

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FDA Proposal for Regulating Laboratory Diagnostics Could Improve Patient Care

Hastings Center Bioethics Forum, September 4, 2014
by Rachel Sachs (Academic Fellow)

From the article:

[...] [T]he FDA's proposal [to regulate laboratory-developed tests] ... coul...

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Teen suicide victim’s eyes were rejected by FDA as donor organs because he was gay

Mail Online, August 15, 2014
by Mail Online Reporter, quoting I. Glenn Cohen (Faculty Director)

From the article:

The FDA has blocked the donation of a teen suicide victim's eyes because he...

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After suicide, gay teen’s eye donation rejected

Washington Post, August 14, 2014
by Ryan Weber, quoting I. Glenn Cohen (Faculty Director)

From the article:

In the Journal of the American Medical Association, Glenn Cohen, a bioethic...

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Ethical issues over experimental Ebola drug

CCTV America, August 13, 2014
by Asieh Namdar, interviewing I. Glenn Cohen (Faculty Director)

Faculty Director I. Glenn Cohen appeared on CCTV America to discuss ethical que...

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Experts urge lifting ban on blood donations by gay men

CBS News, July 25, 2014
by Dennis Thompson , quoting I. Glenn Cohen (Faculty Director)

The United States should repeal a 30-year policy that bans blood donations from gay and bisexual me...

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FDA Regulation of Mobile Health Technologies

NEJM, July 24, 2014
by Nathan G. Cortez, J.D., I. Glenn Cohen, J.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H.

Petrie-Flom Faculty Director I. Glenn Cohen has published a new co-authored article in the New Engl...

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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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FDA Advises Against Morcellator Use in Hysterectomies:

Wall Street Journal, April 17, 2014
by Jon Kamp and Jennifer Levitz, quoting I. Glenn Cohen (Faculty Director)

[...] "The fact that the FDA released this warning makes it more likely that a doctor who went...

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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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The Presumption Against Expensive Health Care Consumption

Tulsa Law Review, Vol. 49, Forthcoming, 2014
by Christopher T. Robertson (Affiliate Faculty)

This essay, as part of a symposium in honor of Professor Einer Elhauge, starts with his recognition...

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