NIH

News & Analysis as of

Medicare, Medicaid, and Enforcement Implications of the 21st Century Cures Act Recently Passed by the House

On July 10th, the U.S. House of Representatives passed the 21st Century Cures Act – medical innovation reform legislation that has been in the works for over a year – by a wide margin (344-77). As Ropes & Gray previously...more

Arnall Golden Gregory Series Explains Provisions in the 21st Century Cures Act

On July 10, 2015, the House of Representatives passed the 21st Century Cures Act by a vote of 344-77. The bill is intended to promote drug and device development, support research and expedite patients’ access to new...more

House Easily Passes 21st Century Cures Legislation, Includes Significant FDA Reforms

On July 10, 2015, the U.S. House of Representatives passed with an overwhelming majority (344-77), the 21st Century Cures bill (H.R. 6), a high-profile bipartisan bill intended to speed up and improve the process for...more

House Passes 21st Century Cures Act

On July 10, 2014, the U.S. House of Representatives overwhelmingly passed legislation intended to speed the approval of drugs and medical devices and increase funding for medical research. The central aim of H.R. 6, the “21st...more

Revised House 21st Century Cures Bill Released Ahead of House Vote

Later this week, the House of Representatives is expected to consider the H.R. 6, the 21st Century Cures Act. Ahead of the House vote, the House Rules Committee released a revised version of the bill with new funding offsets...more

21st Century Cures Act Passes House Committee

The House Energy and Commerce Committee unanimously approved H.R. 6, the “21st Century Cures Act,” on May 21, 2015, after reaching a bipartisan agreement to fund the legislation (Cures bill). Often described as a “landmark...more

Medical Innovation: Congressional Committees Support Accelerated Research and Development for New Drugs, Devices and Biologics

Recent hearings by Senate and House committees and a scheduled markup underscore Congress' continued commitment to eliminating barriers that are slowing the development of effective drugs, devices, and biologics so that...more

Washington Healthcare Update

This Week: CMS Releases Three Documents on Biosimilar Reimbursement... SCOTUS: Agencies, Not State Courts, in Charge of Medicaid Rate Setting... HHS OIG and Treasury IG Release Report on ACA’s Advanced Premium Tax Credits....more

Sharing Clinical Trial Data: A New Era in Life Sciences Has Begun

The European Medicine Agency’s (EMA) Policy on Publication of Clinical Data for Medicinal Products for Human Use (“EMA Policy”)is now effective as of January 1, 2015. Across the Atlantic, the U.S. Institute of Medicine (IOM)...more

Health Care Update - March 2015 #2

In This Issue: - Senate HELP Begins Innovation for Healthier Americans Hearings - 340B Hearing Postponed; Written Testimonies Shed Light on Agenda - Implementation of the Affordable Care Act -...more

Washington Healthcare Update

This Week: Ways and Means Advances Four Health-Related Measures... Senate Commerce Committee Clears Legislation on E-Cigarette Packaging... CMS Pushes Back Deadline on Meaningful Use for Physicians....more

Blog: Congress Eyes Pharmaceutical Company Settlement Agreements as Source for Additional FDA & NIH Funding

Senator Elizabeth Warren (D-MA) recently introduced legislation that, if passed, would require certain pharmaceutical companies that enter into settlement agreements with the Department of Justice or other governmental...more

Details Emerge for President’s Precision Medicine Initiative

Personalized medicine has a friend in high places. President Obama recently announced an initiative to support “precision” or personalized medicine. In very general terms, the President stated during his 2015 State of the...more

Investors Should Note U.S. Medical Research Funding Slows

Investments by the federal government in medical research has declined in recent years, according to the results of a new study published in the Journal of the American Medical Association....more

NIH Announces New One-Grant-at-a-Time Policy

In a move designed to stretch budget dollars and spread the research wealth, the National Institute of General Medical Sciences (NIGMS) announced last week that starting next year, it will impose a one-grant-at-a-time policy...more

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

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