FDA Approval Of Hepatitis C Drugs For Kids Is Likely To Speed Treatment

NPR, April 19, 2017
by Michelle Andrews

With the approval this month of two drugs to treat hepatitis C in children, these often overlooked v...

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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

:

“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

:

“‘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

:


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

:

Democrats’ New Drug Bil

l

Improving Access to Affordable Prescription Drugs...

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Anthem inches closer to full Obamacare exit

POLITICO, March 31, 2017
by Dan Diamond, featuring blog post by Rachel E. Sachs (Academic Fellow Alumna)

From the newsletter

:

WHAT WE'RE READIN

G

Writing at Harvard’s “Bill of Health,&rdqu...

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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

:

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

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Price doesn’t satisfy Congress on appropriations

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

From the newsletter

:

The latest issue of the New England Journal of Medicine is full of eHealt...

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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

:

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

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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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(Health) Law and Order

Beyond the Microscope Podcast, March 28, 2017
by Mumu Xu, interviewing Rachel E. Sachs (Academic Fellow Alumna)

We’ve got a special episode today for all you STEM/legal nerds. Our guest is Rachel Sachs...

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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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Regulating Black-Box Medicine

Michigan Law Review, March 21, 2017
by W. Nicholson Price II (Academic Fellow Alumnus)

From the abstract

:

Data drive modern medicine. And our tools to analyze those data are growing ever...

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‘Right-To-Try’ Laws Expose Dying Patients To Exploitation, Ethicists Warn

Kaiser Health News, March 6, 2017
by Carrie Feibel, KQED

[...] “We know some people try to take advantage of our desperation when we’re ill,&rdqu...

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Why Did That Drug Price Increase 6,000%? It’s The Law

Forbes, February 10, 2017
by Matthew Herper, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

Marathon is a member of the Pharmaceutical Research and Manufacturers of America...

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Trump’s ‘Two Out, One In’ Regulatory Policy May Apply to Some FDA Guidance

Regulatory Affairs Professionals Society (RAPS), February 6, 2017
by Zachary Brennan, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

As far as what existing regulations if repealed would be considered par...

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E&C delays vote on drug pricing bill

Politico, February 6, 2017
by Sarah Karlin-Smith, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

On cost: studies have found that it usually takes a handful of generic drugscompe...

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What You Don’t Know About the Cost of Grandma’s Prescription

Pacific Standard, February 3, 2017
by Carson Leigh Brown, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

To grapple with how and why the process works this way, we talked with Rache...

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Common Rule Revisions: Impact of Public Comment, and What’s Next?

The Hastings Center Blog, February 8, 2017
by By Holly Fernandez Lynch (Executive Director), I. Glenn Cohen (Faculty Director) and Barbara E. Bierer

From the blog post

:

On January 19, the day the final revisions to the Federal Policy for...

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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

;

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

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Trump’s travel ban rattles medical residency programs

Politico Pulse, January 31, 2017
by Dan Diamond, featuring blog post by Rachel Sachs (Academic Fellow alumna)

From the article

:

Trump's order on regulations is a 'terrible idea' for rulemaking.&nbs...

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Morning View 01-31-17

Institute for Clinical and Economic Review (ICER), January 31, 2017
by Mitchell Stein, featuring blog post by Rachel Sachs (Academic Fellow alumna)

From the article

:

The President issued an Executive Order basically saying that for every new regul...

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Vitals

Axios, January 31, 2017
by David Nather, featuring blog post by Rachel Sachs (Academic Fellow alumna)

From the article

:

The executive order could have an especially big impact on implementing the 21st...

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The $4,500 injection to stop heroin overdoses

Washington Post, January 27, 2017
by Shefali Luthra, quoting W. Nicholson Price II (Academic Fellow Alumnus)

From the article

:

Thanks to an infusion of public funding to combat opioid overdoses, other institu...

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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

Promoting healthcare innovation on the demand side

Journal of Law and the Biosciences, January 16, 2017 (online first)
by W. Nicholson Price II (Academic Fellow Alumnus) and Rebecca S. Eisenberg

Abstract: Innovation policy often focuses on fortifying the incentives of firms that develop and sel...

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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

:

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

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PFC Spotlight: Faculty Affiliate Ameet Sarpatwari

The Petrie-Flom Center, January 12, 2017

>Ameet Sarpatwari, J.D., Ph.D., is an Instructor in Medicine at Harvard Medical School, an Assoc...

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The Oxford Handbook of U.S. Healthcare Law

The Oxford Handbooks, July 2016 (online), January 2017 (print)
by Edited by I. Glenn Cohen (Faculty Director), Allison K. Hoffman (Academic Fellow Alumna), and William M. Sage

>Abstract: ;The Oxford Handbook of U.S. Health Law covers the breadth and depth of health law thr... Read More

The FDA Should Approve Drugs Based on Evidence, Not Emotions

Slate, December 13, 2016
by Alan Levinovitz, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

Unlike many other countries, the United States managed to avoid the thalidomide c...

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Funding for Cures Bill Remains Sticking Point for Health Groups

Bloomberg, November 28, 2016
by Anna Edney and Zachary Tracer, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

The Cures bill will fund some prevention efforts, said Lynne Weil, a spokeswoman...

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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

:

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

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House lines up biotech lollipops as support grows for an epic 21st Century Cures Act

Endpoints News, November 28, 2016
by James Carroll, citing Bill of Health blog post by Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

According to Kaiser Health News, more than 1,400 lobbyists have ta...

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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

:

(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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Regulating Off-Label Promotion — A Critical Test

NEJM, November 2, 2016
by Christopher Robertson, JD, PhD (Academic Fellow Alumnus) and Aaron S. Kesselheim, MD, JD, MPH (Faculty Affiliate)

Petrie-Flom Academic Alumnus ;Christopher T. Robertso;and Faculty Affiliate ;Aaron S....

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Drug prices: Where do we go after the Election?

The Conversation US, October 30, 2016
by Rachel E. Sachs (Academic Fellow Alumna)

Martin Shkreli. Valeant Pharmaceuticals. Mylan. These names have become big news, but just a year ag...

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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

:

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

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The Readout: Speaking of Drug Prices

STAT, October 12, 2016
by Damian Garde and Meg Kesh, featuring Rachel Sachs (Academic Fellow alumna)

From the post

:

How? Washington University law professor Rachel Sachs and Department of Veterans Aff...

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Innovation–Innovation Tradeoffs in Drug Pricing

Annals of Internal Medicine, October 11, 2016
by Rachel Sachs (Academic Fellow alumna)

From the article

:

The uproar over the price of the EpiPen is the latest episode in a longstanding c...

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Generic EpiPen Will Likely Secure Profits For Mylan

Law360, September 22, 2016
by Dani Kass, quoting Rachel Sachs (Academic Fellow alumna)

[...] Many customers are still likely to use the branded products once the generic is released,...

Read More

EBOLA and FDA: reviewing the response to the 2014 outbreak, to find lessons for the future

Journal of Law and the Biosciences, September 16, 2016
by Emily A. Largent (Student Fellow alumna)

Abstract

:

In 2014, West Africa confronted the most severe outbreak of Ebola virus disease (EVD) in...

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5 reasons why no one has built a better EpiPen

STAT, September 9, 2016
by Meghana Keshavan, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] But critics say Mylan has little incentive to improve EpiPens: “If you’re the...

Read More

Euro Drug Pricing’s Tradeoffs May Limit Appeal In US

Law360, September 8, 2016
by Dani Kass, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] Going forward, an influx of bills targeting drug prices could be introduced, but few are...

Read More

EpiPen’s Dominance Driven By Competitors’ Stumbles And Tragic Deaths

NPR, September 7, 2016
by Pauline Bartolone, quoting W. Nicholson Price II (Academic Fellow alumnus)

NPR recently called on Petrie-Flom Academic Fellow alumnus Nicholson Price to help explain how...

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Missouri law professor: Consider price controls after Epipen controversy

Missourinet, September 5, 2016
by Jason Taylor, quoting Rachel E. Sachs (Academic Fellow Alumna)

A Missouri law professor thinks Congress should consider imposing price controls on certain drugs af...

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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

:

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

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Mylan’s decision to make a cheaper, generic EpiPen ‘baffles’ experts

Business Insider, August 31, 2016
by Lydia Ramsey, featuring blog post by Rachel E. Sachs (Academic Fellow alumna)

From the article

:

"I and others who study these issues full time cannot understand why Mylan though...

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The FDA Wants To Make It Harder To Buy And Sell Poop

BuzzFeed, August 13, 2016
by by Nidhi Subbaraman, quoting Rachel Sachs (Academic Fellow alumna)

[...] Depending on how the approval is handed down, Rebiotix could very well put outfits like OpenBi...

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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...

Read More

This Could Have Been The First Poop Pill To Hit The Market, But It Failed Clinical Trials

BuzzFeed Science, July 29, 2016
by Nidhi Subbaraman, quoting Rachel Sachs (Academic Fellow alumna)

[...] “I think it is a big deal,” said Rachel Sachs, a professor of health and law...

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A Trojan Horse?

Ohio State Law Journal, 2017 (forthcoming)
by Christopher T. Robertson (Academic Fellow alumnus)

Abstract:      
; Scholars, advocates, and courts have begun to recogniz...

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Need For Blood In Orlando Raises Questions About Wisdom Of Banning Donors Due To Sexual Orientation

Forbes, June 14, 2016
by Rita Rubin, reviewing article by I. Glenn Cohen (Faculty Director), Jeremy Feigenbaum, and Eli Y. Adashi

Excerpt from the article

:

[...] In a 2014 “viewpoint” article in the Journal of th...

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FDA Regulations Limit Blood Donations From Gay Men

CBS San Francisco, June 14, 2016
by Holly Quan, featuring I. Glenn Cohen (Faculty Director)

Excerpt from the article

:

On World Blood Donation Day and in the wake of the Orlando mass shooting,...

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After The Orlando Massacre, Many In The LGBTQ Community Are Turned Away From Giving Blood

Greater Boston (WGBH), June 14, 2016
by Nikki Blank, interviewing I. Glenn Cohen (Faculty Director)

Excerpt from interview

:

Early in the 1980's, there was a lifetime ban or deferral for any man w...

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Preventing Mitochondrial DNA Diseases: One Step Forward, Two Steps Back

Journal of the American Medical Association, June 9, 2016
by I. Glenn Cohen (Faculty Director) and Eli Y. Adashi

From the article

:

On February 3, 2016, the Institute of Medicine (IOM) released its Ethical an...

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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 L...

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Regulatory Specialist
Partners HealthCare

Deadline: June 05, 2016

As a not-for-profit organization, Partners HealthCare is committed to supporting patient care, resea...

Read More

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 stu...

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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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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 the...

Read More

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...

Read More

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

The Weekly Standard, March 21, 2016
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, &l...

Read More

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...

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..

. 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...

Read More

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 i...

Read More

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...

Read More

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...

Read More

Foodborne Outbreaks

Centers for Disease Control

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

Read More

Food Safety

FoodSafety.gov

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

Read More

Codex Alimentarius

World Health Organization

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

Read More

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 pub...

Read More

Harvard Food Law and Policy Clinic

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

Read More

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 basic...

Read More

Food Safety News

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

... Read More

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...

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 played...

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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, Bi...

Read More

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 -...

Read More