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House Passes 21st Century Cures Act

On November 30, 2016, the House of Representatives passed the 21st Century Cures Act, a bill intended to modernize health care delivery and speed up and improve medical research and innovations by removing bureaucratic...more

Congress weighs approval for sweeping, $6.3 billion 21st Century Cures Act

It’s almost 1,000 pages, culminates at least three years of work, and provides a $6.3 billion boost for an array of health-related agencies and initiatives. Will the U.S. Senate join the House in bipartisan passage of the...more

House Passes 21st Century Cures Act

On November 30, 2016, the House overwhelmingly passed (392-26) the 21st Century Cures Act (“Bill”). The Bill moves on to the Senate next week and it is projected to pass in the Senate as well. Notably, the Bill seeks to...more

New HHS clinical trials registry regulations set to go into effect in January 2017: top points in one chart

Nearly a decade after Congress directed significant expansion of the national clinical trials database, www.ClinicalTrials.gov, the US Department of Health and Human Services (HHS) has issued final implementing regulations...more

Capitol Hill Healthcare Update

After months of debate and partisan wrangling, the House on Wednesday voted 392-26 to pass the “21st Century Cures” bill designed to accelerate the development of new drugs and medical devices as well as increase federal...more

More Than the Leaves Are Changing: Clinical Trial Research Regulations and Policies Get a Fall Makeover

The Food and Drug Administration (FDA) and National Institutes of Health (NIH) have recently finalized or signaled intent to finalize numerous proposals that promise to change the landscape of clinical trial reporting,...more

False Claims Act Lawsuits Increasingly Target Universities

Research universities have increasingly become targets for False Claims Act actions, both by private plaintiffs and by the government. Because the FCA began as a statute focused on government procurement and has only more...more

NIH Finalizes New Drug and Device Clinical Trial Reporting Requirements

The National Institutes of Health (NIH) has finalized the requirements for submitting clinical trial information for applicable clinical trials of drug products (including biological products) and device products on...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

Washington Healthcare Update

1. Congress - House of Representatives - House Energy and Commerce Committee Republican Leaders Send Letter to HHS OIG Concerning NIH Grant on Traumatic Brain Injury - On Sept. 15, Republican leaders of the...more

DOJ Files FCA Complaint Against Recipient of Grant Funding

The FCA began as a response to procurement fraud by military contractors during the Civil War. In the intervening years, its reach has extended and increasingly the government is using the FCA as a tool in the context of...more

USP Says European Market Shows Mandatory USP Standards Would Improve Biosimilar Approval, Acceptance in U.S.

Back in March, 2016, the Senate added language to the FDA and NIH Workforce Authorities Modernization Act which would exempt biological products, including biosimilars, from provisions of the FDCA Act that require compliance...more

Once again, retained rights in federally funded, patented drugs will not be asserted to control price

In a previous alert, "What you need to know about retained rights in federally funded patented drugs" (March 24, 2016), we provided background on the US Department of Health and Human Services' and the National Institutes of...more

NIH Signals “Paradigm Shift” with Policy on Multi-Site Studies

Federally-funded clinical trials conducted at multiple sites will move to a single Institutional Review Board (IRB) review scheme under a new National Institutes of Health (NIH) Policy. The NIH has finalized its policy to...more

White House Finalizes Data Security Framework For Precision Medicine Initiative

On May 25, 2016, the White House unveiled the final data security framework for its Precision Medicine Initiative (“PMI”). One of the main goals of PMI is to develop a research cohort for collecting health data from...more

NFL tries to pull a fast one on funding for head-trauma research

What’s $30 million among friends? When the National Football League offered in 2012 to provide that sum to support concussion research by the National Institutes of Health, the conventional wisdom held that the sports...more

NIH takes stronger steps to improve patient safety at Bethesda Clinical Center

Federal officials have decided to sweep out the executive ranks at the flagship hospital of the National Institutes of Health in Bethesda, this after a blue-chip investigating committee rebuked the institution and declared...more

DOJ Files IPR Petitions Against Discovery Patents

The U.S. Department of Justice (DOJ) filed six petitions for inter partes review (IPR) of three patents assigned to Discovery Patents, LLC. The patents cover security alarm systems and methods for providing secure real-time...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

Members of Congress Seek NIH Hearing on Use of March-in Rights

On March 28, 2016, a dozen members of Congress sent a letter to Sylvia Mathews Burwell, the Secretary of the Department of Health and Human Services, and Dr. Francis Collins, the Director of the National Institutes of Health...more

Senate HELP Committee Convenes Third and Final Cures Markup

On April 6, 2016 the Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold its third and final markup for its biomedical innovations package. This package is a compliment to the House-passed 21st Century...more

Blog: Washington Update: Senate proceeds towards “Cures”; CMS releases MA rates and Call Letter

Health care policy issues continue to stream out of Congress and the Administration. The Senate held a markup of various health bills as part of its effort to produce a companion to the House of Representatives-passed 21st...more

FDA Regulatory and Compliance Monthly Recap — March 2016

FDA warning letter calls out exoskeleton device manufacturer for repeatedly avoiding FDA requests for postmarketing surveillance - The FDA sent a warning letter to Argo Medical Technologies after the company averted...more

Washington Healthcare Update

This Week: The House of Representatives and the Senate were on recess…but it was not quiet on the health care front! 1. Congress - House of Representatives - House, Senate Democrats Want NIH to Bring Down...more

What you need to know about retained rights in federally funded patented drugs

The issue of drug pricing is top of mind - More than 50 members of Congress, led by Rep. Lloyd Doggett (D-TX), sent a letter to Secretary of Health and Human Services Sylvia Matthews Burwell and to National Institutes of...more

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