Archive for February, 2014

NIH, Industry and Non-Profits Partner to Speed Validation of Disease Targets

NIH, 10 biopharmaceutical companies and several nonprofit organizations launched an unprecedented partnership on Feb. 4 to transform the current model for identifying and validating the most promising biological targets of disease for new diagnostics...

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A handful of biological indicators can predict a healthy person’s risk of dying within five years.

By Rina Shaikh-Lesko | February 27, 2014 “Four blood-based biomarkers can predict a healthy person’s chance of dying within five years, according to a study published this week (February 25) in PLOS Medicine. A team led by investigators...

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Obama Administration Takes Steps to Ease Patent Process

by: Jared A. Favole Feb 20, 2014 Click here to view the full article on WSJ.com PAYWALL SUMMARY: The Obama administration is taking steps to ease the patent-application process and help consumers who face litigation from...

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A New Approach to Clinical Trials

By Thomas Insel on February 27, 2014 “NIMH has been in the spotlight lately for proposing the Research Domain Criteria or RDoC, a new framework for classifying mental disorders. One of the aims of RDoC is to...

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COMPANY MUST BE IN GOOD STANDING TO MAINTAIN GOVERNMENT CONTRACT LITIGATION

Judge Sheridan notes “In order to maintain this action and for the Board to have jurisdiction over this case, Western States needs to be an LLC in good standing in Delaware, its state of...

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extension of comment period on DOD review of statutory and regulatory requirements

79 Fed. Reg. 10461, February 25, 2014 SUMMARY: The Defense Procurement and Acquisition Policy (DPAP) gives notice that the comment period announced in the February 12, 2014 (79 FR 8402) notice of request for public...

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A Guide to FDA Postmarketing Submission Requirements and Reporting Interactive Promotional Media

From MintzLevin “The FDA’s proposed guidance provides for different treatment of different types of Applicant use of Interactive Promotional Media. The chart below (ON SITE)  provides a visual breakdown of the treatment of each...

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Answers To Common Questions About Abusive Patent Litigation

In June 2013, President Obama ordered the creation of this website to empower those who have received a demand letter or may be threatened with a patent lawsuit with information about their options. In...

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Digital Privacy Notice Challenge

Through the HIPAA Privacy Rule<http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/>, patients have the right to be informed of their rights with respect to their protected health information as well as how their health care providers and health plans may...

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FDA Considers Trials of ‘Three-Parent Embryos’

Science 21 February 2014: Vol. 343 no. 6173 pp. 827-828 DOI: 10.1126/science.343.6173.827 NEWS & ANALYSIS ASSISTED REPRODUCTION Gretchen Vogel An experimental technique, called mitochondrial DNA replacement therapy, that manipulates a woman’s DNA could spare her from passing on...

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