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Medical Research Clinical Laboratories

Maynard Nexsen

Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist

Maynard Nexsen on

Recorded at SCbio’s 2024 annual conference, hosts Heather and Matthew welcome Sarah Glaven, a research biologist and the Assistant Director of Biotechnology and Biomanufacturing for The White House Office of Science and...more

Health Care Compliance Association (HCCA)

[Virtual Event] Research Compliance Conference - November 9th, 8:00 am - 5:00 pm CT

Get the latest strategies and insights for healthcare research compliance - Whether you missed this year’s in-person Research Compliance Conference or are looking for additional insights from research colleagues and...more

Jackson Walker

Key Considerations for Clinical Investigators When Negotiating Clinical Trial Agreements

Jackson Walker on

Clinical trials are an essential component of the research architecture for developing new drugs and devices. Research institutions and their clinical investigators (“Investigators”) play an important role in supporting drug...more

Nelson Mullins Riley & Scarborough LLP

Clinical Research and Patient Data Protection are at a Complicated Intersection

The privacy landscape in the United States and much of the world is quickly evolving around the framework of the General Data Protection Regulation (GDPR) within the European Economic Alliance (EEA). Clinical trials involve...more

McDonnell Boehnen Hulbert & Berghoff LLP

Epigenetic Changes Implicated in Age-related Diminution in Vision and Its Possible Reversal

The Fountain of Youth -- an enduring aspiration, particularly as the ravages of age reduce human faculties prior to leading inexorably to death.  Reduction in sight is the human faculty that can have the greatest effect on...more

Bass, Berry & Sims PLC

How the FDA's EUA for Convalescent Plasma Will Impact Healthcare Providers and Researchers

Bass, Berry & Sims PLC on

On Sunday, August 23, the Food & Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for investigational COVID-19 convalescent plasma (CCP) for the treatment of COVID-19 in hospitalized patients. This EUA...more

Bass, Berry & Sims PLC

FDA Issues Updated Guidance on Clinical Trial Conduct during the COVID-19 Pandemic

Earlier this month the FDA issued guidance listing general factors for study sponsors to take into consideration to assure the safety of clinical trial participants, maintain a good clinical practice, and minimize risks to...more

Morgan Lewis

Back to the Future but Still in Flux: Court Finds Law Requires ClinicalTrials.gov Posting of Ten Additional Years of Additional...

Morgan Lewis on

The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more

Mintz - Health Care Viewpoints

FDA’s Evolving Response to the COVID-19 (Coronavirus) Outbreak

Within the U.S. Department of Health and Human Services (HHS), many agencies have responsibility for responding to public health emergencies. The Centers for Disease Control and Prevention (CDC), as its name implies, is at...more

Bricker Graydon LLP

Clinical trials and Medicare billing: Avoiding false claims liability

Bricker Graydon LLP on

Participating in clinical trials can leave health care providers vulnerable to false claims liability if Medicare rules are not closely followed. This publication reviews settlements involving clinical trials, provides an...more

Health Care Compliance Association (HCCA)

[Event] March Research Compliance Academy - March 9th - 12th, San Diego, CA

HCCA's Health Care Research Compliance Academy is a three-and-a-half-day intensive training program focuses on compliance issues related solely to research. Its faculty is made up of experts in the field. With a wide range of...more

Patrick Malone & Associates P.C. | DC Injury...

With costly medical over-testing, causes can be blurry, solutions complex

Although experts estimate medical over-testing adds more than $200 billion in wasted spending in the U.S. health care system, reducing it can be hard, as we can see from one example in eye surgery....more

Knobbe Martens

Medical Research Organization NAMSA Announces Acquisition of Reimbursement Strategies Consultancy

Knobbe Martens on

NAMSA, which describes itself as “the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research and regulatory consulting services,”...more

Mintz - Health Care Viewpoints

Agencies Extend Comment Period on Proposed Changes to Clinical Research Rules

Those wishing to comment on revisions to the Federal Policy for Protection of Human Subjects (known as the “Common Rule”) could add a 30-day comment period extension to the things they were grateful for at this year’s...more

Foley Hoag LLP

2013-2014: Evolving Challenges for Value-Priced LDTs

Foley Hoag LLP on

Introduction - In 2004, the Genomic Health Oncotype DX breast cancer molecular test was launched and within five years had substantially changed the standard of care for patients with early breast cancers. How has the...more

Mintz - Health Care Viewpoints

Proposed Medicare Cuts Would Significantly Impact Independent Laboratories

Last week, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule setting forth revisions to payment policies under the Medicare Physician Fee Schedule (MPFS) and other revisions to Medicare Part B for...more

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