Speedy Drug Approvals Have Become the Rule, Not the Exception

New York Times, May 1, 2015
by Margot Sanger-Katz

Congress has over the past few decades passed a series of special approval pathways for important d...

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Drug Product Liability Litigation Course

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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.

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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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Bill Would Give F.D.A. More Muscle on Cosmetics

New York Times, April 20, 2015
by Rachel Abrams

For decades, the Food and Drug Administration has had fewer than a dozen pages of instruc...

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Nut So Fast, Kind Bars:

NPR, April 15, 2015
by Poncie Rutsch

If you're deciding between a candy bar and a fruit-and-nut bar, and health is top of mind, the...

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

Tuesday, April 14, 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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“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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Study Warns of Diet Supplement Dangers Kept Quiet by F.D.A.

New York Times, April 7, 2015
by Anahad O'Connor

Popular weight-loss and workout supplements on sale in hundreds of vitamin shops across the nation...

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Breast Milk Sold Online Contaminated With Cow’s Milk

NPR, April 7, 2015
by Michaeleen Doucleff

Selling breast milk is big business.

Each year tens of thousands of women post ads on websites, of...

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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

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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

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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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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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