2017-2018 Petrie-Flom Center Student Fellowship
Harvard Law School

Deadline: August 4, 2017

The Center and Student Fellowship

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

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Science Needs Your Cells

New York Times, April 21, 2017
by Holly Fernandez Lynch (Executive Director) and Steven Joffe

>Biospecimens are essential to medical progress, but just medical waste to patients. Let's promot... Read More

PFC Spotlight: Student Fellow Alumnus Matthew Baum

Petrie-Flom Center, April 13, 2017

>Matthew Baum was a Student Fellow for the 2013-2014 academic year, as a second year MD-PhD...

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Death By 1,000 Cuts: How Republicans Can Still Alter Your Coverage

Kaiser Health News, April 10, 2017
by Jay Hancock, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

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“It’s the single-biggest problem facing the exchanges,” said Ra...

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Congress and FDA nominee heap love on ‘adaptive trials’

Science, April 7, 2017
by Kelly Servick, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

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“‘Adaptive clinical trials’ is one of those buzzwords that get...

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Scott Gottlieb: Conflicts surround Trump’s FDA pick

CNN, April 4, 2017
by Sandee LaMotte, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

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Even some industry watchdogs are cautiously optimistic. In a New England Jo...

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ICER Weekly View 03-31-17

ICER, March 31, 2017
by Mitchell Stein, featuring blog post and NEJM article co-authored by Rachel E. Sachs (Academic Fellow Alumna)

From the review

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Democrats’ New Drug Bil

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Improving Access to Affordable Prescription Drugs...

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Senate will vote to overturn Planned Parenthood protections

POLITICO, March 30, 2017
by Dan Diamond, featuring NEJM article co-authored by Rachel E. Sachs (Academic Fellow Alumna)

From the newsletter

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What the experts are saying. NEJM posted a pair of perspectives that offe...

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Scott Gottlieb’s FDA Commissioner Confirmation Hearing: Remarkably Unremarkable

Health Affairs Blog, April 7, 2017
by Rachel E. Sachs (Academic Fellow Alumna)

From the post

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On Wednesday morning, the United States Senate Committee on Health, Energy, Labor, a...

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Prohibiting sperm donor anonymity in the US and possible effects on recruitment and compensation

BioNews, April 3, 2017
by Andrew Hellman and I. Glenn Cohen (Faculty Director)

From the article

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Many children conceived using donor sperm or eggs want to kno...

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FDA Approves Marketing Of Consumer Genetic Tests For Some Conditions

NPR, April 7, 2017
by Jessica Boddy

The U.S. Food and Drug Administration approved 23andMe's personal genetic test for some diseases...

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Also Made in Mexico

New York Times, March 31, 2017
by Sarah Varney

TIJUANA, Mexico — The North American Free Trade Agreement has transformed this sprawling borde...

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An FDA Commissioner for the 21st Century

NEJM, March 29, 2017
by Amitabh Chandra and Rachel E. Sachs (Academic Fellow Alumna)

President Donald Trump has named Scott Gottlieb as his nominee to be the next commissioner of the Fo...

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Health Law Workshop: Kathryn Zeiler

Monday, March 27, 2017 5:00 PM
Health Law Workshops
2016-2017
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

>Presentation: "Communication-And-Resolution Programs: The Numbers Don’t Add Up

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This paper is...

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Addressing the ethical issues raised by synthetic human entities with embryo-like features

eLife, March 21, 2017
by John Aach, Jeantine Lunshof, Eswar Iyer, and George M. Church

On November 7, 2016, the Petrie-Flom Center hosted the conference "The Ethics of Early Embryo Resear...

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Final Revisions to the Common Rule

U.S. Department of Health and Human Services

On January 19, 2017, federal regulators published the Final Rule to amend and update the Federal Pol...

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Trump Slashes Health Spending In Federal Budget Plan

Kaiser Health News, March 16, 2017

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

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The ad...

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2018 Brocher Foundation Call for Proposals
Brocher Foundation, Switzerland

Deadline: May 07, 2017

Call for proposals for the 2018 events is launched

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The Brocher Foundation offers to rese...

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Mitochondrial Replacement Therapy

JAMA Forum, February 14, 2017
by Eli Y. Adashi and I. Glenn Cohen (Faculty Director)

From the article

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Mitochondrial replacement therapy, an experimental approach that takes aim at mat...

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Call for Papers
European Pharmaceutical Law Review (EPLR)

Deadline: Various

Calll for Paper

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The European Pharmaceutical Law Review (EPLR) provides a forum to discuss, comment...

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Mitochondrial Replacement Therapy: Unmade in the USA

The JAMA Forum, February 14, 2017
by Eli Y. Adashi and I. Glenn Cohen (Faculty Director)

From the article

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Mitochondrial replacement therapy, an experimental approach that takes aim at mat...

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What Experts in Law and Medicine Have to Say About the Cost of Drugs

The Health Care Blog, February 2, 2017
by Andy Oram, on PFC's 5th Annual Health Law Year in P/Review Conference

From the article

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Pharmaceutical drug costs impinge heavily on consumers’ consciousness, ofte...

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Fifth Annual Health Law Year in P/Review

Monday, January 23, 2017 8:30 AM - 5:00 PM
Conferences
2016-2017
Wasserstein Hall, Milstein West AB
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

>Couldn't make it to the event? Check out some of the speakers' slides as well as blog posts... Read More

Regulating Secrecy

Washington Law Review, 2016, Vol. 91, Nr. 4
by W. Nicholson Price II (Academic Fellow Alumnus)

>Abstract: Inventors face a stark choice between two intellectual property systems of protecting... Read More

A New Fertility Technique Could Make ‘Designer Babies’ a Reality

Gizmodo, January 13, 2017
by Kristen V. Brown, quoting I. Glenn Cohen (Faculty Director)

From the article

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In vitro gametogenesis, or IVG, is a technique that could allow any kind of...

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Federal Circuit Court Appeal Cites Rachel E. Sachs

U.S. Court of Appeals for the Federal Circuit, January 13, 2017, No. 17-1480
by Paul D. Clement et al., citing work by Rachel E. Sachs (Academic Fellow Alumna)

No. 17-148
0
UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUI
T  
; AMGEN INC., AMGEN MANUFAC...

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FDA Further Explains Delay on LDT Guidance

Regulatory Affairs Professionals Society, January 13, 2017
by Zachary Brennan, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

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Several praised the move to delay the final guidance, particularly as a new...

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The Legality of Biometric Screening of Professional Athletes

The American Journal of Bioethics , 2017, Vol. 17, Issue 1
by Jessica L. Roberts, I. Glenn Cohen (Faculty Director), Christopher R. Deubert (Senior Law & Ethics Associate) & Holly Fernandez Lynch (Executive Direc

From the article

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In their thoughtful article, “Tracking U.S. Professional Athletes: The Ethi...

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Harnessing the U.S. Taxpayer to Fight Cancer and Make Profits

New York Times, December 19, 2016
by Matt Richtel and Andrew Pollack, quoting Rachel E. Sachs (Academic Fellow alumna)

From the article

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Rachel Sachs, an associate law professor at Washington University in St. Louis an...

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Academic Fellow Alumna Michelle N. Meyer Named in Forbes List of 10 Favorite

Forbes, December 15, 2016
by David Shaywitz

In a year characterized by the extremes of rhetoric, healthcare entrepreneurs have been blessed with...

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Should We Ban Anonymous Sperm Donation?

Vocativ, November 30, 2016
by Tracy Clark-Flory, quoting I. Glenn Cohen (Faculty Director)

From the article

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There’s a push underway to change the way that most sperm is donated&n...

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Call for Abstracts: The Ethics of “Making Babies”
Harvard Medical School

Deadline: January 31, 2017, 5:00 PM

The use of assisted reproductive technologies raises far-reaching ethical and legal implications, ye...

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Morning View 11-28-16: Pharmaceuticals News

Institute for Clinical and Economic Review's Morning View, November 28, 2016
by Mitchell Stein, citing Bill of Health post by Rachel E. Sachs (Academic Fellow Alumna)

From the article

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On Friday, building on the long-standing DC tradition of releasing gargantuan reg...

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Lame duck Congress looks for swift approval of massive medical innovation bill

AJC.com (The Atlanta Journal-Constitution), November 27, 2016
by Jamie Dupree, citing Tweet & Bill of Health post by Rachel E. Sachs (Academic Fellow Alumna)

From the article

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(Tweet by Rachel E. Sachs) My 1st thoughts on today's draft of 21st Cent...

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Using Twitter as an Intelligence Tool: 85 Accounts Worth Following

Regulatory Affairs, November 16, 2017
by Zachary Brennan, citing Twitter accounts of Rachel E. Sachs (Academic Fellow Alumna), Ameet Sarpatwari, Aaron Kesselheim and Amitabh Chandra (Affilia

With the rise of president-elect Donald Trump, it’s become abundantly clear that Twitter matte...

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Online J-Term Health Law Courses
875 Summit Ave. | St. Paul, MN 55105

Deadline: January 02, 2017

The Mitchell Hamline School of Law Health Law Institute is pleased to offer two online health law co...

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Drug Pricing: Where Do We Go After the Election?

Institute for Public Health, Washington University in St. Louis, October 26, 2016
by Rachel Sachs

From the blog post

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Martin Shkreli. Valeant Pharmaceuticals. Mylan. Just a year ago, most Americans...

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Health Law Workshop: W. Nicholson Price II

Monday, October 17, 2016 5:00 PM
Health Law Workshops
2016-2017
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

>Presentation: "Regulating Black-Box Medicine

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This paper is not available for download. To request...

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Professor offers basics of bioethics and the law in 90 minutes

Harvard Gazette, September 20, 2016
by Deborah Blackwell, reviewing lecture by I. Glenn Cohen (Faculty Director)

On September 13, 2016, Petrie-Flom Faculty Director I. Glenn Cohen delivered a lecture at the Harvar...

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Bioethics and the Law of Reproductive Technology and Genetics

Harvard Ed Portal, Allston, MA, September 13, 2016

Genetic enhancements. Reproductive technologies. Animal-human hybrids. Through new technologies and...

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PFC Spotlight: Student Fellow Alumnus Neel Shah

Petrie-Flom Center, September 8, 2016

>Dr. Neel Shah was a Student Fellow for the 2007-2008 academic year, while in his third year at Harva...

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2016 Petrie-Flom Center Annual Open House

Wednesday, September 07, 2016 5:30 PM
Lectures and Panels
2016-2017
HLS Pub, Wasserstein Hall, 1st floor
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

At this event, faculty, colleagues, and students with shared interests in health law policy, biotech...

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Federal Government’s Proposed Expansion of Regulation of Biospecimen Research Should Be Reconsidered

Biopreservation and Biobanking, September 2016
by Christopher T. Robertson and Jonathan D. Loe

>Note: The full article is behind a paywall

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Abstract

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In September, the U.S. Department of Health...

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Bioethics: The Law, Medicine, and Ethics of Reproductive Technologies and Genetics

Petrie-Flom Center, Course begins September 6, 2016. Register now!

>Bioethics: The Law, Medicine, and Ethics of Reproductive Technologies and Genetic

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An introduction...

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Mylan’s sudden plans for a generic EpiPen

Modern Healthcare, Vital Signs Blog, August 31, 2016
by Adam Rubenfire, quoting Rachel E. Sachs (Academic Fellow alumna)

From the post

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Obviously Mylan didn't want to underprice its own branded drug, but it's pos...

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The GMO Labeling Fight Is Not Industry Versus Consumers

Forbes, August 26, 2016
by Steve Ansolabahere and Jacob E. Gersen (Director, Food Law Lab)

From the article

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In late July, President Obama signed a bill requiring some form of labeling of fo...

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The FDA is prohibited from going germline

Science, August 5, 2016
by I. Glenn Cohen (Faculty Director) and Eli Y. Adashi

Petrie-Flom Faculty Director I. Glenn Cohen has co-authored a new article in Science magazine&n...

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5 ways to avoid fighting over frozen embryos

Futurity, July 18, 2016
by David Orenstein-Brown, citing I. Glenn Cohen (Faculty Director)

[...] In a new paper, two experts review this history and propose five specific guidelines. The resu...

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Embryo Disposition Disputes: Controversies and Case Law

Hastings Center Report, July/August 2016, Vol. 46, Issue 5
by I. Glenn Cohen (Faculty Director) & Eli Y. Adashi

Abstract

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When prospective parents use in vitro fertilization, many of them hope to generate more e...

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A designer will grow Alexander McQueen’s skin in a lab to use for leather bags and jackets

Quartz, July 16, 2016
by Marc Bain, quoting I. Glenn Cohen (Faculty Director)

[...] Glenn Cohen, an expert on the intersection of bioethics and law at Harvard Law School, sa...

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Religion and Reproductive Technology

In Law, Religion, and Health in the United States (Holly Fernandez Lynch, I. Glenn Cohen, Elizabeth Sepper, eds.), forthcoming 2017, Cambridge University Press, 2017 (forthcoming)
by I. Glenn Cohen (Faculty Director)

Abstract

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This chapter will examines places where law, religion, and reproductive technology confli...

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Policy Advocacy Manager
DNDi (Drugs for Neglected Diseases initiative), Geneva, Switzerland

Deadline: July 17, 2016

Terms of reference

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Title: Policy Advocacy Manage
r Based: Genev
a Duration: Long term...

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Petrie-Flom Center Student Fellowship 2016-2017
Petrie-Flom Center, Harvard Law School

Deadline: August 05, 2016

THE PETRIE-FLOM CENTE

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STUDENT FELLOWSHIP PROGRAM, 2016-201

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CALL FOR APPLICATION

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The Center and...

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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

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

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Petrie-Flom, 10 years on:

Harvard Law Today, April 14, 2016

On March 29, current and former affiliates of the Petrie-Flom Center for Health Law Policy, Biotechn...

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Health Acceleration Challenge
Harvard Business School & Harvard Medical School

Deadline: May 16, 2016

There are few communities of professionals that are as innovative as those in health care. From inve...

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Associate Editor - Ethics
American Medical Association Journal of Ethics

Deadline: May 27, 2016

Associate Editor – Ethic

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The American Medical Association (AMA), the nation’s largest...

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CRISPR, Are We Ready to Rewrite the Human Genome?

ECUSA Boston, March 24, 2016
by Speaker: Rachel Sachs (Academic Fellow)

Rachel Sachs (Academic Fellow) was a speaker at the ECUSA Boston event "CRISPR, Are We Ready to Rewr...

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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 th...

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Genetically Modified Crops

Foundation of American Scientists

An introduction to genetically modified crops, including key ecological concerns. 

... Read More

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 fo..

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Food, Genetically Modified

World Health Organization

Educational page providing general and technical information on genetically modified foods. 

... Read More

FDA - Guidance and Regulation

U.S. Food and Drug Administration

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

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Genetically Engineered Crops in the United States

United States Department of Agriculture, February 2014

Report by the USDA Economic Research Service on recent trends in adoption of genetically engineered...

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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 govern...

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Food from Genetically Engineered Plants

Food and Drug Administration

This FDA site includes consumer information about food from genetically engineered plants, as well a...

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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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Genetically Engineered Crops: Past Experience and Future Prospects

National Academy of Science

Website announcing NAS study on the benefits and risks of GE crops. 

... Read More

What is a biobank? Differing definitions among biobank stakeholders

Clinical Genetics, March 2014
by Shaw et al.

An article discussing areas of agreement and difference in determining what constitutes a bioba..

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Foodborne Outbreaks

Centers for Disease Control

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

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Bioengineered (Genetically Engineered) Crops and Foods

American Medical Association

AMA statement on genetically engineered crops and foods. 

... Read More

Biorepositories and Biospecimen Research Branch

National Cancer Institute

Website for the BBRB, which provides leadership, tools, resources, and policies in biobanking f...

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Food Safety

FoodSafety.gov

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

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GMOs, Herbicides, and Public Health

New England Journal of Medicine, Aug. 20, 2015
by Philip J. Landrigan and Charles Benbrook

Describes the impact of two recent changes in the GMO landscape, and considers their larger implicat...

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Characterizing biobank organizations in the U.S.

Genome Medicine, Jan. 2013
by Henderson et al.

Results from a national survey of U.S. biobanks, including information on location, reason for...

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Codex Alimentarius

World Health Organization

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

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Principles for Responsible Clinical Trial Data Sharing

PhRMA, EFPIA, Jul. 2013

A joint agreement produced by pharmaceutical trade groups PhRMA and EFPIA, affirming the indust...

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Biobank resources for future patient care: developments, principles and concepts

Journal of Clinical Bioinformation, Sept. 2011
by Ákos Végvári et al

An overview of global biobank development, outlining the critical research role of biobanks and...

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