Medical Research

News & Analysis as of

Six Key Changes to the Common Rule

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more

HHS Finalizes Toned-Down Version of Common Rule Overhaul

The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data...more

Health Alert (Australia) January 30, 2017

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Administrative Appeals Tribunal 23 January 2017 - Shales and Commonwealth Bank of Australia [2017] AATA 53 -...more

Health Alert (Australia) January 23, 2017

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Federal Court 13 January 2017 - Selia v Commonwealth of Australia [2017] FCA 7 - ADMINISTRATIVE LAW -...more

Longitudinal Study Finds that Post-Concussion Syndrome (PCS) May Be Permanent

University of Toronto researchers have just published an important longitudinal study following patients with Post-Concussion Syndrome (PCS) based on a diagnosis of concussion in conformity with the international sport...more

“Rest Until Symptom Recovery” May Not be the Best Medicine for Children and Adolescents Recovering from Acute Concussion

In a study published in the Journal of the American Medical Association (JAMA) on December 20, 2016, Canadian researchers found that children and adolescents who returned to exercise within seven days of experiencing a...more

HHS Finalizes Major Changes to the Common Rule

On January 18, 2017, the U.S. Department of Health and Human Services (HHS), together with fifteen other federal Departments and Agencies, issued a final rule intended to revise and modernize the federal Policy for the...more

The 21st Century Cures Act

Signed into law by President Obama on December 13, 2016, the 21st Century Cures Act (Act) was overwhelmingly supported in both houses of Congress and comprises a dizzying array of provisions aimed to improve and modernize...more

21st Century Cures Act Provides Some Welcome Relief

The 21st Century Cures Act (the “Cures Act”) (Pub. L. No. 114-255), which was signed into law by President Obama on December 13, 2016, includes a number of important health care provisions, and several address the...more

21st Century Cures Act: Key Provisions of Interest to Drug/Device Clients

Included in the many provisions contained in the 21st Century Cures Act are ones addressing drug, device, and biologic development and approval. Topics include the use of “real world evidence” in regulatory approvals, drug...more

21st Century Cures Act offers array of holiday gifts to healthcare providers

The 21st Century Cures Act, a rare beneficiary of broad bipartisan support, has been signed into law by President Barack Obama. The law has received much public acclaim for its $4.8 billion in new funding over the next...more

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more

President Obama Signs the 21st Century Cures Act Into Law

The act creates faster, more flexible FDA drug and biologic review, new drug and device approval pathways, increases FDA funding, and reduces EHR administrative burdens. On December 13, 2016, President Obama signed into...more

The Passage of the 21st Century Cures Act by Congress will produce Sweeping Changes to the Biotech, Medical Device,...

The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

Senate Passes 21st Century Cures Act

Last week, the Senate passed the 21st Century Cures Act, a $6.3 billion medical research bill. The bill authorizes billions of dollars to the National Institutes of Health (“NIH”). ...more

Health Alert (Australia) December 12, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Federal Circuit Court 5 December 2016 - Singh v Minister For Immigration & Anor [2016] FCCA 3061 - MIGRATION –...more

Better Healthcare Newsletter from Patrick Malone - December 2016

Give a lasting holiday gift of health: Volunteer for a medical research study - That toy the kids whined about for weeks may be broken hours after emerging from the box. The gift card you gave will be frittered away,...more

Health Alert (Australia) November 28 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: New South Wales - 23 November 2016 - Tolley v Secretary, NSW Ministry of Health in respect of Northern NSW Local...more

"OFAC and BIS Implement Additional Amendments in Support of Cuba Policy Shift"

On October 14, 2016, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) and the Department of Commerce’s Bureau of Industry and Security (BIS) announced further amendments to ease U.S. sanctions and...more

US Further Liberalizes Cuba Sanctions and Export Controls

On October 14, 2016, the United States announced additional measures to liberalize Cuba sanctions and export controls, effective October 17, 2016. The new measures, which are summarized below, authorize additional...more

Health Alert (Australia) October 17, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: New South Wales 13 October 2016 - Coote v Kelly; Northam v Kelly [2016] NSWSC 1447 - On 23 May 2012, Mr Coote died...more

Obama’s Not Slowing Down On Cuba: New Steps Forward Open Doors (and Humidors!) for Collaboration

With fewer than 100 days left in office, President Obama is not slowing down on his efforts to normalize relations between the United States and Cuba. Today, several changes to the Cuban Assets Control Regulations (CACR) and...more

U.S. Authorities Amend Cuba Sanctions Regulations

On October 17, 2016, the U.S. Treasury Department’s Office of Foreign Assets Control (OFAC) and the Commerce Department’s Bureau of Industry and Security (BIS) issued new amendments to the Cuban Assets Control Regulations (31...more

Health Alert (Australia) October 3, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Fair Work Commission. 23 September 2016 - Francis Logan v Bendigo Health Care Group [2016] FWC 6780 -...more

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