Despite the prevalence of off-label drug prescriptions for pregnant women, little attention is paid to the ethical, legal, and regulatory issues regarding this practice. This paper discusses some of these key issues relevant to the practice of off-label medication use by women during pregnancy.
In June 2013, the U.S. Supreme Court issued a unanimous decision upending more than three decades worth of established patent practice when it ruled that isolated gene sequences are no longer patentable subject matter under 35 U.S.C. Section 101.While many practitioners in the field believed that the USPTO would interpret the decision narrowly, the USPTO actually expanded the scope of the decision when it issued its guidelines for determining whether an invention satisfies Section 101. The guidelines were met with intense backlash with many arguing that they unnecessarily expanded the scope of the Supreme Court cases in a way that could unduly restrict the scope of patentable subject matter, weaken the U.S. patent system, and create a disincentive to innovation. By undermining patentable subject matter in this way, the guidelines may end up harming not only the companies that patent medical innovations, but also the patients who need medical care. This article examines the guidelines and their impact on various technologies.
Google “opioid abuse deterrence” and you’ll find a lot of hits from lawyers and elected officials. What you won’t find is a lot of expert thinking from the FDA.
That needs to change. FDA Commissioner Hamburg’s March 13, 2014 testimony in front of the Senate HELP Committee) hopefully represent a more aggressive stance by the agency. That’s good. But there needs to be more. The FDA must be the leading voice on the issue of abuse deterrence and the safe use of opioids.
At present, politicians and pundits (not to mention trial lawyers) own the conversation. They're the ones talking about it. They're the ones the media goes to when they write about it. Have a look at a sampling of the press coverage surrounding Zohydro and see who's quoted and what they're saying.
The struggle over control of the opioid abuse deterrence story is, shall say, not going the right way for the FDA.
With passage of the Leahy-Smith America Invents Act (AIA), new rules and procedures related to the application of prior art now apply to patenting under a “first-inventor-to-file” system. This article summarizes certain key prior art provisions that biotechnology companies should be aware of and details practical steps that can be implemented to help stake a competitive advantage under the new law including the use of patent liaisons, early provisional and patent application filings, and in certain circumstances, defensive publication of patentable subject matter.
I report on five years’ testing of what makes a happy team, using students in a Bioscience Entrepreneurship Masters programme at Cambridge University as a test-bed. I looked at measures of personality (using the IPIP test for the Big Five personality characteristics) and a measure of work style derived from the time of submission of work that I term Deadline Brinkmanship. I find that teams selected to have a similar working style are generally happier working together than those selected by other criteria. Entrepreneurial activity is uncorrelated with psychological characteristics in this study, but is slightly correlated with working style and the willingness to accept a “good enough” result now rather than an ideal result in the future. I conclude that it is important for a nascent entrepreneurial team to work together on an important, deadline-driven task before committing to a new venture.
This article describes the initiative and actions related to establishing a Digital Health Consortium (DHC) at the University of Colorado Denver. The consortium is a part of the Center for Information Technology Innovation (CITI) in the Business School. The objective is to augment existing information systems program offerings in health information technology with the support of industry affiliates and other partners of the university. The CITI-DHC is an industry-academia led initiative with a mission to accelerate digital health transformation through education, research, and service. We illustrate the vision and plan for the consortium, that will be fulfilled with academic and industry stakeholders, and who will be engaged with the platform to support digital health care innovations through collaborations.
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