News & Analysis as of

Clinical Trials

August 2017 – Regulating CRISPR genome editing in humans: where do we go from here?

by Allen & Overy LLP on

The use of genome-editing techniques in medical therapies has proved to be a promising development in the treatment of certain diseases, such as cancer, HIV and rare diseases, by genetically altering specific types of cells....more

Do the Waive – FDA Implements Informed Consent Waivers for Minimal Risk Studies

by Hogan Lovells on

On July 25, 2017, FDA issued a guidance document describing under what circumstances IRBs may now approve consent procedures that waive or alter some or all of the elements of informed consent as set forth in FDA’s informed...more

Human Germline Genome Editing – Genetics bodies weigh in on debate with position paper

by Allen & Overy LLP on

In an article published in American Journal of Human Genetics on 3 August 2017, an international group of 11 organisations with genetics expertise has issued a joint position statement, setting out 3 key positions on the...more

FDA Clarifies Consent Requirements for Certain Minimal Risk Clinical Investigations

by Morgan Lewis on

FDA’s guidance, which permits institutional review boards to waive informed consent for certain clinical investigations, may facilitate valuable personalized medicine research....more

Boehringer Ingelheim Announces Start Of Adalimumab Biosimilar Interchangeability Study

by Goodwin on

Last week, Boehringer Ingelheim announced that it had enrolled the first patient into its VOLTAIRE-X interchangeability study. This Phase 3 study will investigate the interchangeability of BI’s adalimumab biosimilar...more

How Not To Create an “Exception” to the Learned Intermediary Rule

by Reed Smith on

We’ve heard more about the constitutional “emoluments clause,” Art 1 §9, clause 8, this year than during the entire rest of our legal careers. But while it’s illegal for anybody working for the U.S. government to accept...more

FDA Establishes Electronic Privacy, Security, and Reliability Criteria for Clinical Trial Records

by Jones Day on

In March 1997, the Food and Drug Administration ("FDA") published a final rule, codified in 21 CFR Part 11 ("Part 11"), establishing the privacy, security, and reliability criteria for electronic records and electronic...more

EMA’s revised Guideline on first-in-human trials increases the level of protection of trial participants

by Hogan Lovells on

The European Medicines Agency (EMA) has released a new Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products. The Guideline was adopted by...more

Bevacizumab Biosimilar Update

by Goodwin on

There has been some recent activity regarding proposed biosimilars to Roche’s Avastin (bevacizumab). Avastin is indicated for the treatment of various types of cancers, including colorectal, lung, and kidney cancer....more

FDA Issues Immediately Effective Guidance Allowing Waiver of Informed Consent for Minimal Risk Research

by Ropes & Gray LLP on

The United States Food & Drug Administration (FDA) has issued a guidance document announcing its intention not to object to an IRB’s waiving or altering the informed consent requirements for an FDA-regulated clinical...more

OIG Approves Cost-Sharing Arrangement Involving Clinical Research Study

by Baker Ober Health Law on

The U.S. Department of Health and Human Services, Office of the Inspector General (OIG), issued a favorable advisory opinion, No. 17-02, regarding a proposed arrangement under which the cost-sharing amounts owed by...more

FDA Issues New Guidance on IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

As July comes to an end, the Food and Drug Administration (FDA or agency) has issued a new guidance document for “immediate implementation” entitled “IRB Waiver or Alteration of Informed Consent for Clinical Investigations...more

Review Article Supports Interchangeability of Infliximab and CT-P13

by Goodwin on

Last week, an article reviewing the literature comparing infliximab biosimilar CT-P13 (Celltrion) with infliximab (Janssen Biotech) for the treatment of rheumatologic diseases was published in Drug Design, Development and...more

Follow the Money: FDA Issues New Procedures for Evaluating Financial Ties Between Application Sponsors and Clinical Investigators

by Hogan Lovells on

In a potential sign of renewed interest in financial ties between industry and clinical investigators, the Food and Drug Administration’s (FDA) Office of New Drugs (OND) recently issued a new Manual of Policies and Procedures...more

EMA Calls for Public Consultation on Clinical Trial Protocol, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

June 2017 The EMA has opened for public consultation a draft guideline for the notification of serious breaches of the Clinical Trial Protocol (Regulation (EU) No 536/2014)...more

EMA Green Lights New EudraVigilance System for Adverse Reactions, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

On May 22, 2017, the European Medicines Agency ("EMA") announced the full functionality of the new EudraVigilance system for the collection and monitoring of suspected adverse reactions with medicinal products that are...more

Guidance for Companies Picking a State for Operations in the U.S.

New District Court Opinion Discussing the Scope of Specific Jurisdiction After Bristol-Myers Squibb Co. v. Superior Court of San Francisco County,582 U.S. ____ (2017) – Wow, that was quick! A District Court Judge from the...more

New French Decree Clarifies the Scope of Biomedical Research, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

French Decree n° 2017-884 of May 9, 2017, was adopted to implement certain provisions of the Legal Ordinance of June 16, 2016, with respect to biomedical research. Such research should now be referred to as "research...more

Here’s why you’re getting those unsolicited mailings about clinical trials

When consumers around the country started getting letters from a company that they had never heard of, inviting them to participate in clinical trials for medical conditions that they hadn’t disclosed to many or didn’t even...more

HHS Subjects Human Research to an Updated Common Rule

by Alston & Bird on

The Department of Health and Human Services has taken a step toward harmonizing the complex regulatory requirements for federal human subjects research. Our Health Care Group breaks down the changes to the Common Rule due to...more

NIH Begins Beta Test of Million Patient Cohort

by Foley & Lardner LLP on

The National Institutes of Health announced the enrollment of the first participants as beta testers of the “All of Us” research program. Initially branded as the “Precision Medicine Initiative®” Cohort Program, “All of Us”...more

Adalimumab Biosimilar Demonstrates Non-Inferiority For Efficacy and Safety

by Goodwin on

At the EULAR Annual Congress this week, Rieke H.E. Alten, MD, working at the University of Berlin, presented data from a randomized, double-blind, Phase III study comparing adalimumab and FKB327, Fujifilm Kyowa Kirin...more

All or Nothing at All: Brexit Update for Life Sciences Companies

by Arnall Golden Gregory LLP on

A lot of ink has been spilled in projecting what Brexit (the UK’s withdrawal from the European Union) might look like, including in this space by this author. The simple fact is that we don’t know what Brexit will actually...more

New Data Supports Efficacy and Safety of Celltrion’s Rituximab Biosimilar

by Goodwin on

Celltrion Healthcare presented new data on their Rituximab biosimilar Truxima® (CT-P10) at the International Conference on Malignant Lymphoma (ICML) in Switzerland and the European League Against Rheumatism (EULAR) Congress...more

To certify or not to certify? FDA has answered the question

by Hogan Lovells on

On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors  should submit Form FDA 3674...more

268 Results
|
View per page
Page: of 11
Cybersecurity

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.