This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology
The DNA/RNA market to 2010
Go to paperABSTRACT: The DNA/RNA market is currently at an early stage of development, with only two marketed products that t…
This is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s post?
Biotechnology in Countries Starting with "I" – Part 6: Iceland Read Post »
This is a guest post from Isabela Oliva. Do you have a response to Isabela’s post? Respond in the comments section
This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology
Solid organ xenotransplantation: Progress, promise and regulatory issues
Go to paperABSTRACT: Xenotransplantation, the process of transplanting live cel…
Solid organ xenotransplantation: Progress, promise and regulatory issues Read Post »
This is a guest post from Zhen-Xia Chen. Do you have a response to Zhen-Xia’s post? Respond in the comments
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-labe…
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.
USPTO Guidance On Patentable Subject Matter: Impediment to Biotech Innovation? Read Post »
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.