Medical Research Medical Devices

News & Analysis as of

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 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

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

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

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

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

Health Alert (Australia) September 19, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: South Australia - 13 September 2016 - Dang Pharmacy P/L v Dang [2016] SADC 106 - This is a review of a decision by...more

Health Alert (Australia) August 15, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: New South Wales - 11 August 2016 - Health Care Complaints Commission v Sheldrick [2016] NSWCATOD 105 - Ms Sheldrick...more

Health Alert (Australia) August 8, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Queensland - 28 July 2016 - Beven v Brisbane Youth Service Inc [2016] QSC 163 - The plaintiff, Lindsey Beven, was...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

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) - 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

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

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

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

HHS Proposes Major Overhaul of the Common Rule

On September 8, 2015, the Department of Health and Human Services proposed significant revisions to the Federal Policy for the Protection of Human Subjects (“Common Rule”), the set of federal regulations governing the conduct...more

House Passes Medical Innovation Bill That Would Revise HIPAA

On July 10, the U.S. House of Representatives approved the 21st Century Cures Act (the Act), a bill intended to support advancements in medical innovation. The Act includes measures aimed at spurring medical research,...more

Arnall Golden Gregory Series Explains Provisions in the 21st Century Cures Act

On July 10, 2015, the House of Representatives passed the 21st Century Cures Act by a vote of 344-77. The bill is intended to promote drug and device development, support research and expedite patients’ access to new...more

House Easily Passes 21st Century Cures Legislation, Includes Significant FDA Reforms

On July 10, 2015, the U.S. House of Representatives passed with an overwhelming majority (344-77), the 21st Century Cures bill (H.R. 6), a high-profile bipartisan bill intended to speed up and improve the process for...more

House Passes 21st Century Cures Act

On July 10, 2014, the U.S. House of Representatives overwhelmingly passed legislation intended to speed the approval of drugs and medical devices and increase funding for medical research. The central aim of H.R. 6, the “21st...more

Health Alert (Australia) - July 6, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: Victoria. 26 June 2015 - Northern Health v Kuipers [2015] VSCA 172 - The Victorian Supreme Court has allowed an appeal...more

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