Medical Research

News & Analysis as of

Rare Genomics Institute Announces Crowdfunding Initiative for Rare Diseases

Earlier this month, Rare Genomics Institute, an international non-profit that makes cutting edge research technologies of genome sequencing, physicians and scientists around the world accessible to rare disease patients,...more

Law Review Articles That Caught Our Eye

Maybe our motto here at DDLaw should be “we read law review articles so you don’t have to.” Here are a couple of recent ones that looked interesting to us....more

Genes Associated with ALS Identified

One of the promises of the Human Genome Project was that knowledge of the entirety of the human genetic complement would permit researchers to identify genetic bases for diseases that had been intractable to conventional...more

Health Alert (Australia) - May 11, 2015

In This Issue: Judgments, Legislation; and Reports and Publications. Excerpt from Legislation: Commonwealth - 5 May 2015 - Australia New Zealand Food Standards Code — Standard 1.4.2 — Maximum Residue...more

Health Care E-Note - April 2015

In This Issue: - New Smartphone Software Provides Groundbreaking Opportunity for Medical Research - The Many Levels of Supervision - Health Care Business Today: A Historical Perspective on Health Care...more

Health Alert (Australia) - April 13, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Reports: 27 March 2015 - Public consultation opens on draft Principles and guidelines for the care and use of non-human primates for scientific...more

Washington Healthcare Update

This Week: House Approves FY 2016 Budget Proposal... House Passes Permanent SGR Reform and Two-Year CHIP Reauthorization... Senate Passes FY 2016 Budget Plan... HHS Report: ACA Led to $7.4 Billion Decline in Uncompensated...more

Perspectives on the President’s Precision Medicine Initiative

President Obama’s “precision medicine initiative” earmarked over $200 million from his proposed 2016 budget to “bring us closer to curing diseases like cancer and diabetes – and to give all of us access to the personalized...more

FDA Issues Draft Guidance on Use of Electronic Informed Consent in Clinical Trials

On March 9, 2015, the U.S. Food and Drug Administration (FDA) released a draft guidance, Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers, that provides recommendations for clinical...more

If You Think You’re Safe from FDA Scrutiny Because You’re in an Ivory Tower, Think Again

FDA increases enforcement based on clinical research violations. According to recently-posted data, 2014 was a banner year for FDA enforcement based on clinical research violations. ...more

Apple’s ResearchKit Turns iPhones into Medical Devices

Apple recently released ResearchKit, an open-source software platform that allows scientists to gather medical data using an individual’s own iPhone. According to The Asian Age, the new platform allows iPhone users to easily...more

Health Alert (Australia) - March 16, 2015

In This Issue: Judgments; Legislation; and Publications & Reports. Excerpt from Publications & Reports: American Medical Association (AMA) - 12 March 2015 - New AMA, CDC Initiative Aims to 'Prevent...more

Health Alert (Australia) - March 9, 2015

In This Issue: Judgments; Legislation; and Reports. - Excerpt from Judgments: Australia. Federal Court - 5 March 2015 - Australian Nursing and Midwifery Federation v Kaizen Hospitals (Essendon) Pty Ltd...more

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

60 Results
|
View per page
Page: of 3

All the intelligence you need, in one easy email:

Great! Your first step to building an email digest of JD Supra authors and topics. Log in with LinkedIn so we can start sending your digest...

Sign up for your custom alerts now, using LinkedIn ›

* With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name.
×