Medical Research

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Scientific Fraud: an acute malady - don't be blinded by it

It seems lately that the healthcare industry has had some horrible and ghastly press time in the media. It's unfortunate that there a number of people who seem to partake in questionable activities that flood the industry...more

Academic Medical Centers: Clinical Care, Research and Teaching (or Maybe Not?)—Graduate Medical Education and the Future

In the world of healthcare policy and law, we usually discuss issues impacting providers, but don’t often report about the training and infrastructure behind what allows our healthcare system to treat patients in our...more

Deadline Looms for New PCORI Grant Applications

Wednesday the Patient-Centered Outcomes Institute announced the availability of up to $76 million in new grant money for comparative effectiveness research projects. But the deadline for prospective applicants to submit...more

FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act

Biologics are large molecules made from, derived from, or extracted from a natural source such as a human, animal, or microorganism that are used in the treatment, diagnosis, or prevention of disease. Biologics include...more

Keeping Our Kids Healthy: Pediatric Medicine Development

Children are a precious commodity and it is important that they are cared for appropriately. Children deserve the best care so they can grow and live happy and fulfilled lives. Pediatric products development is in high demand...more

FDA Publishes New Draft Guidance on Biosimilars As Congress Raises Questions About FDA’s Use of Draft Guidance Documents

As we previously reported, the U.S. Food and Drug Administration (“FDA”) has been drafting guidance regarding the regulation of biosimilars since as early as 2011. A biological product is biosimilar if it is “highly similar...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

FDA Releases Draft Guidance on Biosimilars - Sets Forth Clinical, Pharmacology Data Sufficient to Support Biosimilarity

The Food and Drug Administration has released the first new Guidance relating to its evolving standards for satisfying the biosimilarity requirements of the Biologics Price Competition and Innovation Act (BPCIA) since its...more

IARC Advisory Group Recommends Multi-Walled Carbon Nanotubes as High Priority

An International Agency for Research on Cancer (IARC) Advisory Group met on April 7-9, 2014, to recommend priorities for IARC Monographs during 2015-2019. The Advisory Group assessed the responses to a call for nominations...more

Putting Testosterone to the Test

Testosterone is the new big drug on the market. Marketed to men with ow T, a vague illness with even vaguer symptoms, there has been a recent explosion in its use. In line with this explosion are also the vast amounts of ways...more

Clones Not Patent-Eligible?

Thanks to recent advances in cloning technology, treating degenerative diseases with replacement tissue that matches a patient’s genetic makeup exactly is no longer science fiction. Just last month, for example, two research...more

Androgen Study Group Pushes for Retraction of JAMA Testosterone Study

The Journal of the American Medical Association Under Fire - The battle is on for plaintiff’s attorneys looking to litigate testosterone replacement therapy (TRT) cases – one of two pivotal studies in relation to TRT...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

Medical Journal Studies on the Health Effects of E-Cigarettes May Help Local Governments

Evidence continues to drift out of the scientific community as to the health effects of e-cigarettes. The latest, a study by the Journal of Adolescent Health as reported by Stephanie M. Lee on SFGate.com. ...more

Council of the European Union and European Parliament Agree on Proposal for New Clinical Trials Regulation

When Approved by the European Parliament, the Regulation Will Have the Force of Law in All EU Member States and Repeal the Current Clinical Trial Directive - On December 20, 2013, the General Secretariat released the...more

China Releases Vaccine Good Clinical Practices

On October 31, 2013, The China Food and Drug Administration (“CFDA”) promulgated a regulation titled Guiding Principles for the Quality Management of Clinical Studies on Vaccines (“Vaccine GCP”), with immediate effect. The...more

OIG Not Asleep at the Switch: Reviews Polysomnography Services from 2011

The OIG recently released its review of polysomnography services (sleep studies) provided in both hospital-based outpatient settings and non-hospital settings. Medicare pays for sleep studies to diagnose obstructive sleep...more

St. Jude's Hospital Sues Novartis over Research Tool Patents

Lest anyone think that Myriad Genetics is the only patentee asserting rights in patents having claims to isolated DNA molecules or other biological molecules, St. Jude's Children's Research Hospital, Inc. has sued Novartis...more

OIG Releases Report on Questionable Billing for Sleep Studies; CMS to Take Action

The Office of the Inspector General (OIG) released a report earlier this month on Medicare spending on polysomnography (sleep studies to diagnose and guide treatment for conditions such as sleep apnea), which indicated that...more

Update on WARF Stem Cell Patent Challenge

As reported in my July 8, 2013 post, Consumer Watchdog (formerly known as The Foundation for Taxpayer and Consumer Rights) and the Public Patent Foundation (collectively “CW”) asked the Federal Circuit to determine if in...more

2013-2014: Evolving Challenges for Value-Priced LDTs

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

Study Advances Personalized Medicine for Newborns

Earlier this year, the American Academy of Pediatrics (AAP) and the American College of Medical Genetics and Genomics (ACMG) issued recommendations and proposed best practices for genetic testing and screening of infants and...more

FTC Complaint Against Medical Laboratory Signals Agency’s Continued Intent to Assert Authority in Data-Security-Breach Actions

In taking action against medical laboratory LabMD, the U.S. Federal Trade Commission demonstrated its continued intent to assert authority through the Federal Trade Commission Act in data-security-breach actions. On August...more

Authors of Genome Medicine Article Form Genetic Testing Company

In a paper published in March in the journal Genome Medicine, Dr. Jeffrey Rosenfeld of the University of Medicine & Dentistry of New Jersey and Dr. Christopher Mason of Cornell University contended that due to the...more

Northwestern University Settles Cancer Research False Claims Act Lawsuit

On July 30, 2013, the United States Attorney’s Office for the Northern District of Illinois announced that Northwestern University entered a settlement agreement to pay the United States $2.9 million to settle False Claims...more

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