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NIH

Window On Washington - Vol. 2, Issue 20

by Clark Hill PLC on

Outlook for This Week in the Nation's Capital - Farm Bill Re-vote? Last week’s vote on the farm bill failed after the Freedom Caucus refused to support the measure. A roll call vote on the motion to reconsider was postponed...more

Patenting and regulation of methods for creating three-parent babies

by Knobbe Martens on

A new infertility technique, mitochondrial replacement therapy (MRT), has been used to create so called “three-parent” babies. MRT is used in cases when mothers carry genes for mitochondrial diseases. Similar to in vitro...more

Health Care Policy Newsletter

by Foley & Lardner LLP on

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our second “Public Policy Weekly* Health Care Newsletter” in which we compile the latest health care policy news and legislation. Please...more

Capitol Hill Healthcare Update

by BakerHostetler on

CONGRESS RECONVENES, WITH A FOCUS ON OPIOIDS - Lawmakers return today to Capitol Hill after a two-week recess, and multiple committees in both the House and Senate are poised to examine the opioid crisis and potential...more

NIH May Own Gilead's Blockbuster Hepatitis Drug Due to Misstep

by Pepper Hamilton LLP on

Every year, the National Institutes of Health (NIH) spends billions of federal dollars on research and development of new drugs and therapies for treating and preventing serious illnesses....more

University of North Texas Health Science Center Agrees to Pay $13 Million to Settle Claims Involving Federal Grants

by King & Spalding on

On February 16, 2018, the U.S. Attorney’s Office for the Northern District of Texas announced that the University of North Texas Health Science Center (UNTHSC) had agreed to pay $13,073,000 to the United States to settle...more

Keeping up with NIH rules impacting research involving human subjects

by Bricker & Eckler LLP on

The National Institutes of Health (NIH) made a number of changes to the rules impacting research involving human subjects in recent years, including the launch of several new initiatives that fall into two categories: those...more

Trump Administration Fiscal Year (FY) 2019 Budget and Healthcare Programs

by Holland & Knight LLP on

The Trump Administration on Feb. 12 released its Fiscal Year (FY) 2019 budget request, titled "An American Budget." Unlike last year's budget, which was released in late May, the release of this budget conforms to the typical...more

House, Senate Proposals to Extend Funding for the Federal Government

by Holland & Knight LLP on

Congress moved one step closer to avoiding a government shutdown on Feb. 6, voting overwhelmingly (245-182) to pass a short-term, GOP-backed government funding bill (text; section-by-section) that would keep the federal...more

Capitol Hill Healthcare Update

by BakerHostetler on

With the government shutdown entering its third day, the Senate scheduled a procedural vote at noon today that could pave the way to end the stalemate – but it’s not clear there’s enough support to break the logjam and reopen...more

Opioid Epidemic Likely to Become a Workplace Issue for Maryland-Area Employers

by Miles & Stockbridge P.C. on

Drug overdoses are now the leading cause of death for Americans under the age of 50. Of the drugs contributing to these deaths, prescription opioids, heroin, and the synthetic opioids, such as fentanyl, have risen...more

Capitol Hill Healthcare Update

by BakerHostetler on

Lawmakers returning to Capitol Hill this week after the Thanksgiving recess face a daunting series of tax and budget deadlines that will set the stage for how Congress addresses year-end healthcare priorities. That...more

Window on Washington - Vol. 1, Issue 34

by Clark Hill PLC on

Short-term Continuing Resolution Likely Needed to Fund Government Past December Deadline: Republicans are focused on tax reform through Thanksgiving, and when lawmakers return from the upcoming holiday recess, they will have...more

Get your Single IRB lined up for Multi-Site Research

by Akerman LLP - Health Law Rx on

Changes to the federal regulations governing the protection of human subjects participating in research (known as the Common Rule) were amended earlier this year. The changes to the Common Rule impact research conducted,...more

FDA Approves First Qualified Health Claim about Allergy Prevention on Baby Food Labels

by Proskauer - Advertising Law on

Last month, the FDA announced that companies will be able to label baby food products with advice about how the early introduction of peanuts in an infant’s diet may reduce the risk of developing a peanut allergy. This marks...more

Window On Washington - This Week in the Nation's Capital - Issue 29

by Clark Hill PLC on

Hurricane Supplemental Includes $29B for Disaster Aid and Flood Insurance: Of the $29B, the National Flood Insurance Program will receive $16B to pay flood claims. The House plans to pass the bill next week and the Senate the...more

GOP senators trying to sneak in one more push to repeal, replace Obamacare

As the 40th President of the United States used to mutter, well, there they go again. The Republicans in the 115th Congress apparently will make another go at repealing and replacing the Affordable Care Act, what may be...more

Window on Washington - This Week in the Nation's Capital - Vol. 1, Issue 22

by Clark Hill PLC on

House Rules Committee Posts Text of Spending Bills, Striking DACA Provision: House Rules Committee posts text for eight appropriations bills, striking language in the fi­nancial services spending bill allowing participants in...more

Fame, reputation and a med school dean’s secret life

Although smaller community hospitals may provide treatments that are as good and as safe, Americans flock to academic medical centers for specialized care and complex procedures. They’re lured to the big, pricey institutions...more

Harmonization of Clinical Research Requirements—Conflicting Common Rule and CLIA Requirements Come under the Microscope

by McDermott Will & Emery on

A complex—and occasionally, inconsistent—patchwork of federal and state regulatory requirements apply to entities that perform human subjects research in the United States. In recognition of one such inconsistency, the...more

Healthcare Weekly Preview from ML Strategies – June 2017 #3

Welcome back everybody. In general, this week insurers will submit their applications for participating in the Marketplace for 2018. After this we will begin to find out where the insurance deserts are and how much rates will...more

NIH Begins Beta Test of Million Patient Cohort

by Foley & Lardner LLP on

The National Institutes of Health announced the enrollment of the first participants as beta testers of the “All of Us” research program. Initially branded as the “Precision Medicine Initiative®” Cohort Program, “All of Us”...more

Trump Administration Releases Fiscal Year 2018 Budget Proposal

by Baker Donelson on

On Tuesday, May 23, the White House released the President's fiscal year 2018 (FY18) budget, launching a contentious and consequential debate that is expected to last through the end of the fiscal year and possibly beyond....more

Trump Administration FY 2018 Budget and Healthcare Programs

by Holland & Knight LLP on

The Trump Administration released on May 23, 2017, its full Fiscal Year (FY) 2018 budget request, titled "A New Foundation for American Greatness." President Donald Trump's request builds off of the administration's March 16...more

Let’s Get Clinical: ClinicalTrials.gov Reporting Requirements Now in Effect

by Arnall Golden Gregory LLP on

The compliance date for the Final Rule implementing the clinical trial reporting requirements of Section 801 of the Food and Drug Administration Amendments Act (FDAAA), also known as FDAAA 801, arrived on April 18, 2017. The...more

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