Nov 2013

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The Israeli Clinical Trials Conference will be held on November 18 in Ramat Gan (Hebrew).

On September 30, 2013 the FDA released a final guidance document, Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies. This audio conference will provide an opportunity for FDA to further explain this guidance and to answer your questions. The FDA held an audio conference on October 23rd, a transcript, audio recording and slides is available at: http://www.fda.gov/Training/CDRHLearn/ucm162015.htm#ide

On November 7, 2013, the FDA released the final guidance document, Design Considerations for Pivotal Clinical Investigations for Medical Devices.  This final guidance clarifies the FDA’s thinking on important premarket clinical study design issues and outlines principles and techniques for developing higher quality studies.  It complements existing guidance on clinical studies by providing specific examples of different study designs, relevant principles to apply in the choice of study design and techniques for sustaining the quality of clinical studies. Following this announcement, the FDA will hold a webinar on December 4, 2013 to further clarify the guidance and provide an opportunity to ask questions one may have regarding the guidance document.

BioNegev Launches 6 Companies. The global innovation center for biotechnology and life sciences in the Negev Israel is a partnership of three major organizations in the Negev: Ben Gurion University of the Negev, Development Authority and the Municipality of Be’er Sheva. The group, was established to operate as a framework for the development of the biotechnology industry and life sciences in the Negev. Six Israeli companies from the Biotechnology and Life Sciences Field are already in.

Big tech scrambles for Israeli firms. Technology companies are on a shopping spree in Israel, spending billions on ever larger deals and fueling the country's startup success story. Google, Apple, Intel, IBM and Cisco have all been involved in a spate of high-profile acquisitions over the past two years, scouring the country for the next big thing. Dealogic data shows a big increase in activity in the sector, with nearly $4 billion in acquisitions of registered Israeli tech firms since 2012. But given this figure only includes deals where a valuation is made public -- and most deals are kept private -- the overall tally is likely to be much higher.