News & Analysis as of

NIH

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

Capitol Hill Healthcare Update

by BakerHostetler on

Legislation reauthorizing FDA user fees for prescription and generic drugs, biosimilars, and medical devices won wide bipartisan approval last week in a Senate committee, teeing up approval by the full Senate, likely after...more

Congress boosts NIH funding but CDC, drug czar’s office aren’t faring as well

Although its battles over health insurance have dominated the headlines, Congress also provided a glimmer of good news on funding for medical research. Lawmakers, at least for this fiscal year, shunned President Trump’s...more

Complicated Landscape Awaits New FDA Commissioner

by Holland & Knight LLP on

A poet from West London once wrote, "Meet the new boss, same as the old boss," a frustrated statement lamenting that the status quo in any system tends to prevail despite calls for revolution. If one judges the potential for...more

Capitol Hill Healthcare Update

by BakerHostetler on

Eight weeks after its introduction, legislation to “repeal and replace” the Affordable Care Act (ACA) won House approval today by a 217-213 vote. Vice President Mike Pence on Sunday said a vote in Congress to repeal the ACA...more

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

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