Medical Research

News & Analysis as of

U.S. Trade Representative Issues 2016 Special 301 Report

On April 27th, Ambassador Michael B.G. Froman, U.S. Trade Representative (USTR), issued the 2016 Special 301 Report. According to the USTR website, "[i]ntellectual property is a critical source of economic growth and...more

Reducing the Delay Between FDA Approval and CMS Reimbursement Coverage

The Centers for Medicare & Medicaid Services (CMS) recently confirmed that the Parallel Review program (first announced in 2010 and most recently extended until December 18, 2015) will be made permanent. ...more

Health Alert (Australia) - May 9, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: JUDGMENTS Commonwealth. Federal Court 29 April 2016 - Australian Competition and Consumer Commission v Reckitt...more

NIH clinical center in Bethesda rebuked for failing to put patients first

A venerated research and care institution that happens to be in our neighborhood got a rebuke and a reminder about its need to put patients first, ensuring that their care doesn’t get trumped by research needs. A...more

Senate HELP Committee Completes Work on Bipartisan “Cures”/Medical Innovation Legislation

The Senate Health, Education, Labor and Pensions (HELP) Committee has approved the last of its biomedical innovation bills that form its counterpart to the House 21st Century Cures Act. Together with the bills cleared by the...more

Health Alert (Australia) - April 4, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: - Victoria 22 March 2016 - De Bruyn v Victorian Institute of Forensic Mental Health [2016] VSC 111 The...more

Weighing risks and benefits: Cannabis, pain reduction, and opioid abstinence

In a recent study that has been accepted for publication in The Clinical Journal of Pain, researchers assessed the long-term effect of medical cannabis treatment on pain and other outcomes (including sleep problems) in people...more

Health Alert (Australia) - February 8, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: South Australia 28 January 2016 - Inquest into the death of Ebony Simone Napier The South Australian Coroner has...more

Health Alert (Australia) - February 1, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Administrative Appeals Tribunal 22 January 2016 - JLSP and Innovation Australia [2016] AATA 23 This...more

President Obama Establishes “White House Cancer Moonshot Task Force” Led by VP Biden, Calls for $1 Billion Investment in Cancer...

President Obama recently signed a memorandum formally establishing a White House Cancer Moonshot Task Force to coordinate and strengthen federal and private efforts to support cancer research and treatment. The Task Force,...more

Health Alert (Australia) - January 25, 2016

In This Issue: -Judgments; Legislation; and Reports -Excerpt from Judgments Commonwealth. Fair Work Commission 15 January 2016 - Lawrence v Calvary Home Care Services Ltd [2016] FWC 175 This...more

HHS Recognizes Changing Environment of Research: Still Time to Comment

Late last month the Department of Health and Human Services (HHS) and other Federal Departments and Agencies announced an extension until January 6, 2016 to the comment period for the Federal Policy for the Protection of...more

Washington Healthcare Update

This Week: Obamacare repeal passes Senate and goes to the House... Tax extenders still under development... Focus on drug pricing continues... Congress looks to create an omnibus appropriations bill to fund the government by...more

Agencies Extend Comment Period on Proposed Changes to Clinical Research Rules

Those wishing to comment on revisions to the Federal Policy for Protection of Human Subjects (known as the “Common Rule”) could add a 30-day comment period extension to the things they were grateful for at this year’s...more

HHS Grants 30-Day Extension on Comment Period for Common Rule Revisions

Today, the Department of Health and Human Services (“HHS”) published a Federal Register notice that extends the comment period for the Federal Policy for the Protection of Human Subjects (“Common Rule”) notice of proposed...more

Australia Biotech Week showcases sophistication and growth

On October 9, Australia's biotech community completed its annual pilgrimage to Melbourne at the conclusion of Australia Biotech Invest 2015 and AusBiotech 2015. This year's conferences once again evidenced the primacy and...more

IRS Adjusted ACA Fee Amounts for the 2015/2016 Policy or Plan Years and Additional Payment Options

The Patient-Centered Outcomes Research Institute (PCORI) fee was established under the Affordable Care Act (ACA) to advance comparative clinical effectiveness research. The PCORI fee is assessed on issuers of health insurance...more

101 Patient Organizations Ask Congress to Curb IPR Abuse

Last month, in a letter to the Senate and House Committees on the Judiciary, 101 patient organizations expressed "concern[] that, as currently written, H.R. 9 [the Innovation Act] falls short of preserving important patent...more

Also In The News - Health Headlines - October 2015 #2

HHS Publishes Final Federal Health IT Strategic Plan 2015-2020 – On September 21, 2015, the Office of the National Coordinator for Health Information Technology (ONC) of HHS laid out the federal government’s final version of...more

ONC Releases Final Health IT Strategic Plan, Draft Interoperability Standards Advisory

The Office of the National Coordinator for Health Information Technology (ONC) has released its final Federal Health IT Strategic Plan for 2015-2020. The 50-page document details how the federal government intends to...more

Health Alert (Australia) - October 5, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: Victoria. Epichealth Pty Ltd v Yang [2015] VSC 516 The Supreme Court has granted an interlocutory...more

Expect Focus – International, Summer 2015

In This Issue: - TTIP’s Impact on U.S. and EU Trade Relations - Proposed Innovation Box Legislation - Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014 - Rules...more

Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014

The U.S. Department of Justice (DOJ) obtained a record $5.69 billion in settlements and judgments from civil cases involving fraud and false claims against the government in fiscal year 2014. This marks the first time the DOJ...more

OHRP to Host Oct. 20 Meeting on Proposed Overhaul of Common Rule

On October 20, 2015, the HHS Office of the Assistant Secretary for Health, Office for Human Research Protections (OHRP) is hosting a public town hall meeting to respond to questions related to its September 8, 2015 proposed...more

HHS Issues Proposed Rule That Would Revise the Federal Policy for the Protection of Human Subjects

Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more

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