News & Analysis as of

Medical Research

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

Health Alert (Australia) 17 July 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 26 June 2017 - Dr Praneal Dutt Sharma v Dr Phillip Segal and Dr Greg Chen [2017] NSWSC 867 - CONTRACT – commercial agreement...more

Biomedical Research Advocacy

by Fox Rothschild LLP on

Like many other animal-related businesses universities, researchers, pharmaceutical companies, their suppliers, associated businesses and non-profit trade associations, are facing increasing scrutiny by the public who...more

IARC Will Convene Advisory Group in 2018/2019 to Consider Nominations

To assist the International Agency for Research on Cancer (IARC) in selecting agents for review in future Monographs, IARC regularly convenes international, interdisciplinary Advisory Groups to review all public nominations...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

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

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

“Come See Our World” Presented By Americans For Medical Progress

by Fox Rothschild LLP on

American for Medical Progress (AMP), “a nonprofit organization dedicated to protecting society’s investment in biomedical research,” just launched an important new educational tool for the public to see and understand the...more

Health Alert (Australia) 29 May 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 12 May 2017 - White v State of Queensland (Central Queensland Hospital and Health Service) [2017] QIRC 41 - INDUSTRIAL LAW –...more

Health Alert (Australia) 22 May 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 16 May 2017 - Realview Holdings Pty Ltd And City Of Busselton [2017] WASAT 71 - Town planning - Development application - Land use...more

Health Alert (Australia) 15 May 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 5 May 2017 - Inquest into the death of Heather Fotiades [2017] NTLC 012 Medical practitioners prescribing high dose opioids for...more

Congress boosts NIH funding but CDC, drug czar’s office aren’t faring as well

Although its battles over health insurance have dominated the headlines, Congress also provided a glimmer of good news on funding for medical research. Lawmakers, at least for this fiscal year, shunned President Trump’s...more

2017 Omnibus Agreement: Key Health Provisions

by Polsinelli on

Congress has completed action on H.R. 244, the “Consolidated Appropriations Act for FY 2017” [P. L. 115-31]. This bipartisan legislation, which funds the Federal government for the balance of the fiscal year, passed the House...more

Health Alert (Australia) May 1, 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 21 April 2017 - ILS Rehab Pty Ltd v Josephine Borg (as administrator of the estate of the late Damien Robert Borg) [2017] NSWSC 442...more

Health Alert (Australia) April 24, 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 11 April 2017 - Medical Board Of Australia and Nuttall [2017] WASAT 58 - National Law - Professional misconduct - Advice - Lacking...more

New Research Shows Potential to Prevent Medical Device-Related Infections

by Knobbe Martens on

A research team from Trinity College Dublin has recently discovered a way to reduce the incidence of medical device-associated infection resulting from biofilms. The term “biofilms” refers to organized colonies of bacteria...more

Fake news? Trolls? Science, medical journals struggle with online woes

Online trolls who have wreaked havoc on traditional news sources also are bedeviling scientific and medical publications. Although experts have benefited from much greater access to information about studies and key...more

Trump's Proposed 2018 Budget Will Double FDA User Fees

by Foley & Lardner LLP on

During his speech last month to a joint session of Congress, President Trump called out the U.S. Food and Drug Administration for its “slow and burdensome approval process.” Those comments came on the heels of Trump’s...more

Health-Related Programs Face Deep Cuts In President Trump’s “Budget Blueprint to Make America Great Again”

On March 16, 2017, President Trump Administration released his first budget outline for the 2018 fiscal year (FY 2018). In an effort to “shrink the role of government,” the $1.1 trillion budget proposal calls for a $54...more

FDA User Fee Hearings Picking Up Steam on Capitol Hill

As we noted previously in our introductory blog post on the 2017 User Fee Act (UFA) reauthorization process, the first UFA hearing on Capitol Hill was convened on March 2, 2017 by the House Energy & Commerce Committee’s (E&C)...more

Updates to the Common Rule for the Protection of Human Subjects Research

On Sept. 8, 2015, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rule Making (NPRM) to seek input on changes to the Federal Policy for the Protection of Human Subjects, otherwise known as...more

President’s budget ax takes a big whack at medical, scientific funding

The Trump budget for the federal government would be a huge step back from investment in medical research with consequences for many years in progress on promoting health and fighting disease....more

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

by Foley & Lardner LLP on

Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more

Health Alert (Australia) March 13, 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Fair Work Commission 7 March 2017 - Mrs Glenyce Ham v Dr Allan Clarke T/A CJ Orthopaedics Pty Ltd [2017]...more

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