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Medical Research

Burns & Levinson LLP

The Importance of Context with Genetic Privacy

by Burns & Levinson LLP on

As consumers, when we think of privacy, one of the first adjectives that springs to mind should be “inconsistent.” Consumers claim to want their personal information used only for the purposes they originally provided it, and...more

Patrick Malone & Associates P.C. | DC Injury...

Better Healthcare Newsletter from Patrick Malone - November 2018

A few sound methods can protect you from rising tide of published medical bunk - Medical hype flourishes in the media-saturated modern world, with the internet testing consumer gullibility 24/7. But for a dozen years, an...more

Verrill Dana LLP

Tag, You’re It: FDA Issues Guidance Ahead of Revisions to its Human Subjects Protection Regulations

by Verrill Dana LLP on

Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued new guidance (“Guidance”) for sponsors, investigators, and institutional review boards (“IRBs”) regarding how recent changes to the Federal Policy for...more

Hogan Lovells

FDA aims to harmonize its human subject protection regulations with Common Rule

by Hogan Lovells on

On October 12, FDA published guidance for sponsors, investigators, and IRBs titled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.”  ...more

Hogan Lovells

The new Belgian Biobank legislation will apply on 1 November 2018: are you ready?

by Hogan Lovells on

The new Belgian Royal Act of 9 January 2018 on Biobanks will apply on 1 November 2018. The Royal Act implements Article 22 of the Belgian Law of 19 December 2008 on the procurement and use of human body material for human...more

Smart & Biggar

Certificate of Supplementary Protection Regime: First Anniversary Update

by Smart & Biggar on

September 21, 2018 marked the first anniversary of the certificate of supplementary protection (CSP) regime. CSPs, which provide an additional patent-like protection term, are intended to partly compensate innovators for the...more

K&L Gates LLP

OCR Clarifies Confusion Related to Authorizations for Ongoing and Future Research Purposes

by K&L Gates LLP on

As mandated by the 21st Century Cures Act of 2016 (the “Cures Act”), in June 2018 the Office for Civil Rights (“OCR”) issued guidance clarifying how individual authorizations under the Privacy Rule of the Health Insurance...more

Knobbe Martens

Microbiome Regulation Emerges From the Shadows: FDA to Co-Host Workshop on Live Cell Therapeutics

by Knobbe Martens on

Research supporting the role of the microbiome in human, animal, and plant health continues to grow at a staggering rate. While the wave of new health technologies emerging from this research rises, companies working in the...more

Wilson Elser

Follow the Yellow Brick Road

by Wilson Elser on

The disease known as chronic traumatic encephalopathy (CTE) is detected at autopsy. Using immunohistochemical staining technology, pathologists look for abnormal depositions of hyper-phosphorylated tau protein, a substance...more

Wilson Sonsini Goodrich & Rosati

FDA Pulls Back the Veil on Surrogate Endpoints

A surrogate endpoint is a clinical measurement—associated with a specific treatment—that indicates whether the treatment may provide a statistically significant clinical benefit. A possible example of a surrogate endpoint is...more

Smart & Biggar

First judicial consideration of Vanessa’s Law: Health Canada must disclose requested clinical trial data

by Smart & Biggar on

In the first case calling upon a court to interpret and apply Vanessa’s Law, the Federal Court has ordered Health Canada to release requested complete copies of all sections of all clinical study reports and all electronic...more

Bricker & Eckler LLP

FDA issues guidance on use of EHR data in clinical research

by Bricker & Eckler LLP on

Many hospitals and health systems conduct sponsored clinical research at their facilities, and clinical trial agreements typically require that sponsors and clinical investigators have access to certain data regarding the...more

K&L Gates LLP

In the Weeds: Navigating the Shifting Federal Regulation of Medical Marijuana

by K&L Gates LLP on

The federal government’s view of medical marijuana is evolving as the U.S. Food and Drug Administration (“FDA” or “Agency”), on June 25, 2018, approved Epidiolex, the first drug containing cannabidiol (“CBD”), a marijuana...more

Hogan Lovells

FDA aims to foster gene therapy developments with six new draft guidance documents

by Hogan Lovells on

Yesterday, FDA’s Center for Biologics Evaluation and Research (CBER) published six draft guidances relating to gene therapy, three of which cover products for specific disease categories (hemophilia, rare diseases, and...more

Patrick Malone & Associates P.C. | DC Injury...

Will medical researchers turn away Big Tobacco’s billion-dollar Trojan horse?

Big Tobacco seems to have a shiny new billion-dollar Trojan horse. The question now: Will medical scientists be savvy enough to avoid a credibility catastrophe by rejecting funding from  Tobacco’s wealthy new foundation?...more

Jones Day

FDA Draft Guidance Regarding Inclusion of Pregnant Women in Clinical Trials

by Jones Day on

The Situation: Pregnant women have historically been excluded from clinical trials due to concerns about the potential for adverse effects on pregnant women and their fetuses. The Development: The U.S. Food and Drug...more

Bergeson & Campbell, P.C.

EPA Issues Final Rule Delaying Compliance Date for Human Subjects Policy by Six Months; Institutions May Utilize Three...

by Bergeson & Campbell, P.C. on

On June 19, 2018, sixteen federal agencies, including the U.S. Environmental Protection Agency (EPA), issued a final rule delaying until January 21, 2019, the general compliance date for 2017 revisions to the policy governing...more

Ropes & Gray LLP

Revisions to Common Rule Delayed Until January 21, 2019

by Ropes & Gray LLP on

In January 2017, the federal departments and agencies that follow the Federal Policy for the Protection of Human Subjects, typically referred to as the Common Rule, issued a Final Rule substantially revising and modernizing...more

McDermott Will & Emery

Blazing New Trails in Health Care and Technology Innovation Ventures

by McDermott Will & Emery on

As the health industry evolves to meet consumer expectations for better quality, lower-cost and more convenient health care options, the demand for technology-driven innovation is accelerating as is the level of interest and...more

Patrick Malone & Associates P.C. | DC Injury...

NIH ripped for Big Alcohol funding and advising on $100-million drinking study

The National Institutes of Health, perhaps the world’s leading medical research institution, has moved fast to try to fix self-inflicted damage to its reputation caused by a controversial $100-million study on alcohol and its...more

Bricker & Eckler LLP

New guidance from OCR regarding protected health information

by Bricker & Eckler LLP on

The U.S. Department of Health and Human Services Office of Civil Rights (OCR) has issued new guidance on HIPAA and individual authorization of uses and disclosures of protected health information (PHI) for research, as called...more

Murtha Cullina

OCR Issues Guidance on the Use of HIPAA Authorizations for Research

by Murtha Cullina on

This week, the Department of Health and Human Services Office for Civil Rights (OCR) issued guidance on the use of HIPAA-compliant authorizations for research based on a mandate in the Cures Act for such guidance. The...more

Cooley LLP

Blog: FDA Issues First of Four Draft Guidances Related to Patient-Focused Drug Development

by Cooley LLP on

The U.S. Food and Drug Administration (FDA) released guidance titled, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input (Guidance 1), to address how stakeholders can collect and submit...more

Wilson Sonsini Goodrich & Rosati

What You Need to Know About the Right to Try Act and Patient Access to Experimental Drugs

Recently, President Donald Trump signed into law the Right to Try Act of 2018 (RTTA).1 The RTTA represents the federal version of laws previously passed by a majority of the states, but with important differences. This WSGR...more

Holland & Knight LLP

Right to Try Law Enacted by Congress: Implementation Unclear

by Holland & Knight LLP on

On May 30, 2018, President Trump signed the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2018. The bill allows the provision of certain unapproved, investigational drugs to patients...more

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JD Supra Privacy Policy

Updated: May 25, 2018:

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Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

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Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

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Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

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Changes in Our Privacy Policy

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Contacting JD Supra

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Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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