News & Analysis as of

Medical Research

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

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

Six Key Changes to the Common Rule

by Epstein Becker & Green on

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

by McDermott Will & Emery on

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

by DLA Piper on

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

by DLA Piper on

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

by Downs Rachlin Martin PLLC on

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

by Downs Rachlin Martin PLLC on

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

by Ropes & Gray LLP on

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

by Baker Ober Health Law on

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

by Foley & Lardner LLP on

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

by Reed Smith on

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

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