NIH

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NIH Issues Proposed Rule Expanding Clinical Trial Registration and Reporting Obligations

On November 21, 2014, the National Institutes of Health (“NIH”) published a notice of proposed rulemaking regarding requirements for clinical trial registration and the reporting of results (“Notice” or “Proposed Rule”)....more

Is Obesity an Environmental Problem?

Like Canada, environmental contamination gets blamed for a lot of things wrong in America. But a recent study in a respected NIH journal, Environmental Health Perspectives, offers a novel expansion of what in our lives that...more

Health Care Update - October 2014 #4

In This Issue: - Ebola Response Taking a Multifaceted Approach - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional Initiatives - Other...more

Health Care Update - October 2014 #3

In This Issue: - Policymakers Scrambling to Contain Ebola Crises - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional Initiatives -...more

Africa Update - October 2014 #3

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub-Saharan Africa - General Africa News - Excerpt from...more

Health Care Update - October 2014 #2

In This Issue: - First Look at Pioneer ACO Data Reveals Murky Path Forward - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional...more

Top NIH-funded U.S. Universities 2014

On Monday, Genetic Engineering and Biotechnology News (GEN) published a list of the Top 50 NIH-funded U.S. universities in fiscal year October 1st – September 30th. Geographically, California leads the list of most Federal...more

FDA Set to Regulate LDTs - Citing Safety Concerns and Advanced Technologies

Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that...more

Health Care Update - July 2014 #3

In This Issue: - First Guidance following Hobby Lobby released - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State...more

Health Care Update - July 2014

In This Issue: - E&C continues to push for bipartisan efforts to improve drug pipeline - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Health Care...more

Weekly Update Newsletter - May 2014 #2

In this issue: - The Wait is Over..GSA Awards OASIS Contracts to 74 Businesses - OMB Issues Notice to Announce the Availability of the 2014 OMB Circular A-133 Compliance Supplement - NIH Launches $20...more

Accelerating Biomedical Innovation, Cures to Patients, and "Out of the Box" Thinking at 21st Century Cures Roundtable

A bipartisan group of Members, led by Energy & Commerce Committee Chairman Fred Upton (R-MI) and Oversight & Investigations Subcommittee Ranking Member Diana DeGette (D-CO), launched the 21st Century Cures Initiative, an...more

Medical Research Fraud And HHS's Office Of Research Integrity: Watching The Watchdog

Even for those who carefully follow legal developments in the health care fraud arena, the Department of Health and Human Service’s Office of Research Integrity (“ORI”) is an agency that rarely appears on the radar. According...more

Health Care Reform Update -- January 21, 2014

In this issue: Implementation of the Affordable Care Act; Other Federal Regulatory Initiatives; Other Congressional and State Initiatives; and Hearings and Mark-Ups Scheduled. Excerpt from Implementation of the...more

Health Care Reform Update -- December 16, 2013

In This Issue: Implementation of the Affordable Care Act; Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; and Hearings and Mark-Ups Scheduled. Excerpt from...more

NIH Declines to Exercise March-in Rights over Abbott Laboratories' Norvir®

Last week, the National Institutes of Health denied a petition from a coalition of "public interest" groups who petitioned the agency to exercise so-called "march-in rights" under provisions of the Bayh-Dole Act against...more

The Government Shut Down and Its Impact on Public Health

In the early morning of October 1, 2013, the U.S. federal government officially went dark. The shutdown came in the aftermath of the Senate’s decisive vote to reject a House plan that would have kept the government funded for...more

Mintz Levin Health Care Qui Tam Update -- Recent Developments and Unsealed Cases: September 2013

Trends and Analysis - ..We have identified 24 health care-related qui tam cases unsealed since last month’s Qui Tam Update. Of those, only 2 were filed in 2013. Nearly half were filed before 2011. ..Among the 24...more

Paying for Family Vacations With NIH Funds Triggers FCA Lawsuit and Settlement

Northwestern University will pay $2.93 million to settle a federal False Claims Act (FCA) lawsuit brought by a former employee who alleged Northwestern allowed a researcher to submit false claims under certain cancer research...more

NIH Implements New Policy on HeLa Genomic Data

On Wednesday, the National Institutes of Health (NIH) announced that the agency had reached an understanding with the family of Ms. Henrietta Lacks regarding access to genomic data for the HeLa cell line, which was derived...more

Patents, Genetic Testing, and Federal Funding

In a July 12, 2013 letter to Dr. Francis S. Collins of the National Institutes of Health (“NIH”), Senator Patrick J. Leahy urged the NIH to exercise its march-in rights under the Bayh-Dole Act to directly license the genetic...more

Senator Leahy Urges NIH to Use March-In Rights on Myriad BRCA Test

On Friday, Sen. Patrick Leahy (D-VT) sent a letter to Dr. Francis Collins, the Director of the National Institutes of Health (NIH), "to urge [the Director] to consider using march-in rights under the Bayh-Dole Act to ensure...more

President Obama’s FY 2014 Budget Proposal - Analysis Related To Administration Funding And Policy Priorities

INTRODUCTION - On April 10th, President Obama submitted his FY 2014 Budget Proposal to Congress. In the normal course of events, the President would have unveiled his spending plan in early February as required by law....more

Healthcare Provisions In The American Taxpayer Relief Act - The Good, The Bad And The Ugly

In late night action on December 31, 2012, the American Taxpayer Relief Act of 2012 (ATRA) was passed by the Senate and finalized days later by Congress and the President with a set of tax and spending policy provisions...more

Supreme Court Will Not Hear Stem Cell Funding Petition

..The on again, off again nature of federal funding for human embryonic stem cell (hESC) research has created a great deal of uncertainty for academic scientists, major research medical centers, venture capital investors,...more

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