Medical Research

News & Analysis as of

Clinical Trial Data: Shared Resource or Private Property?

In a recently released report titled “Sharing Clinical Data – Maximizing Benefits, Minimizing Risks,” the U.S. Institute of Medicine (IOM) has called for more clinical trial data transparency. Historically, participant-level...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

Lawsuits Piling up Against Makers of Risperdal, Invega

Antipsychotic Drugs Have Caused Breast Growth in Men - More than two years after Johnson & Johnson settled a lawsuit with a 21-year-old man who experienced an adverse side effect from Risperdal, hundreds of other young...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

Medical Device Clinical Trial Data from Johnson & Johnson To Be Made Available

According to MedicalXpress, expansive data from a company’s medical device clinical trials will soon be made broadly available to medical device researchers for the first time.  The Yale University Open Data Access (“YODA”)...more

Social Media Use for Clinical Trial Recruitment

Social media can be an effective and easy way to connect with friends and professional contacts. However, it can also serve as a tool for institutions and principal investigators involved in enrolling subjects in clinical...more

FDA Regulatory and Compliance Monthly Recap – November 2014

In an unusual move, the FDA takes issue with the accuracy of Sciecure’s studies in a warning letter over sales promotion material for the company’s sleeping pill - In addition to criticizing the pharmaceutical company...more

Warning: No Sandbagging Experimental Evidence

Baxter Healthcare Corp. v. Millenium Biologix, LLC - The U.S. Patent and Trademark Office Patent Trial and Appeal Board (PTAB or Board) has explained that an inter partes review (IPR) petitioner should fully support...more

Office for Human Research Protections Releases Draft Guidance

On October 24, 2014, the Office for Human Research Protections (OHRP) announced in the Federal Register that it has released, and is seeking comment on, its Draft Guidance on Disclosing Reasonably Foreseeable Risks in...more

Privacy Issues in the Sharing of Genetic Information

Scientific breakthroughs and technological advancements have led to the emergence of personalized medicine — a practice based on the use of an individual's genetic profile to guide health care decisions made about the...more

Administration Moves to Address Antibiotic Resistance

On September 18, 2014, the Obama administration announced a comprehensive initiative to combat the growing threat of antibiotic-resistant bacteria. The initiative centers largely on preventing overuse of antibiotics and...more

Is CMS Feeling the Sunshine Heat? – Part 2

As follow-up to our recent post on the issues that the Centers for Medicare & Medicaid Services (CMS) is experiencing with its Open Payments database, there is new information that additional data also may be excluded when...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

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

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