News & Analysis as of

NIH

Window on Washington - Vol. 1, Issue 3

by Clark Hill PLC on

Budget/Appropriations - Spending Talks: House and Senate appropriators continue efforts to nail down an agreement on a stopgap spending measure to avert a government shutdown after the expiration of the current...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

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

Trump Administration Budget Rocks Medical Research Advocates

by Faegre Baker Daniels on

The skinny on President Trump’s slimmed down Fiscal Year 2018 budget is anything but positive for advocates of medical research. In a White House budget officially released the morning of Thursday, March 16, the...more

Trump Administration Proposes 17.9% Cut to HHS Programs, Doubling of FDA User Fees

by Reed Smith on

The Trump Administration is calling for deep cuts to Department of Health and Human Services (HHS) funding for fiscal year (FY) 2018 along with a $1 billion hike in Food and Drug Administration (FDA) user fees in its “budget...more

More Time to Streamline: NIH Extends Deadline for Implementation of Single IRBs for Funded Studies

by BakerHostetler on

The research community has a full plate as it sifts through the final rule on the Common Rule issued last week. Many are now fully appreciating the December gift from the National Institutes of Health that granted an...more

Uncertainty rises about leadership in nation’s top health posts

Although attention has focused on the GOP-promised repeal and replacement of the Affordable Care Act, other big changes also are afoot in the federal government that will have significant effects on health care in this...more

21st Century Cures: A Closer Look

by McDermott Will & Emery on

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

Washington, D.C. Update – December 2016

by Baker Donelson on

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

by Baker Donelson on

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

by Bass, Berry & Sims PLC on

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

by McDermott Will & Emery on

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

by Morgan Lewis on

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

by McCarter & English, LLP on

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

by Ropes & Gray LLP on

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

by Latham & Watkins LLP on

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

by Shipman & Goodwin LLP on

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

by K&L Gates LLP on

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

by King & Spalding on

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

by Cozen O'Connor on

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

by DLA Piper on

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

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