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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

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

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