NIH

News & Analysis as of

Washington, D.C. Update – December 2016

With the last-minute passage of a Continuing Resolution (CR) to stave off a government shutdown, the 114th Congress has come to an end. When Congress returns in January, it will be faced with a number of immediate challenges,...more

21st Century Cures Passes Congress and is Signed into Law

After more than four years of halting progress, Congress approved and the President signed the 21st Century Cures Act. The legislation, which passed the Senate 94 to 5 and the House 392-26, authorizes $6.3 billion in...more

21st Century Cures Act - HIPAA & Other Privacy Considerations

On December 13, 2016, President Obama signed the 21st Century Cures Act (the Cures Act) into law. The Cures Act addresses a wide range of healthcare topics including clinical research, treatment of mental health and substance...more

21st Century Cures: Modernizing Public and Private Research

The 21st Century Cures Act, signed into law by President Obama on December 13, encourages biomedical research investment and facilitates innovation review and approval processes. Through National Institutes of Health (NIH)...more

21st Century Cures Act’s Effect on Pharmaceutical and Biotechnology Industries

The 21st Century Cures Act contains significant new mandates for both the FDA and NIH that affect the pharmaceutical and biotechnology industries and are intended to advance drug research, discovery, approval, and promotion...more

Universities Are Prime Targets for False Claims Act Liability

Colleges and universities receive billions of dollars in federal funds, whether through research grants or student financial aid, or even by billing Medicare or Medicaid for services rendered at academic medical centers. As a...more

21st Century Cures Act – Provisions Relating to Regulation of Clinical Research

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate. With an overarching goal of advancing biomedical...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 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

Implications of the Medicare and Medicaid Provisions in the 21st Century Cures Act

On December 7, 2016, Congress passed the 21st Century Cures Act (the “Act”). The Act began as a proposal to increase funding to the National Institutes of Health (“NIH”) and streamline the Food and Drug Administration’s...more

Landmark Mental Health Bill Creates Unique Opportunity for Connecticut Providers

Something refreshing actually came out of the U.S. Congress last week. In a rare display of bipartisanship, the Senate voted 94 to 5 to pass the 21st Century Cures Act, which is being called the most comprehensive mental...more

Did Big Pharma & medical device makers win most in 21st Century Cures Act?

President Obama is expected to sign the $6.3 billion 21st Century Cures Act, capping a rare, multi-year, bipartisan push to significantly improve the nation’s health care. The Senate, with Vice President Biden presiding and...more

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

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