Ethics/Regulatory

Ireland reiterates bid to host the EMA

Wednesday, May 10, 2017

Ireland has stepped up its bid to host the EMA with the official announcement being delivered and reiterated by Minister of Health, Simon Harris. The next step will now see Dublin scrutinized closely, particularly in regard to its regulatory capability. Ireland’s strength lies in the close relationship that the Health Products Regulatory Authority (HPRA) has established with the EMA and the wider network of medicines regulatory agencies throughout the EU. The HPRA has been an integral part of this regulatory system since the EMA was founded more than two decades ago.

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Stricter medical device regulations will improve patient outcomes

Thursday, May 4, 2017

Regulations for medical and diagnostic devices are changing in tune with advances in technology, new and innovative medical treatments, and the need for more effective diagnostic practices. Infiniti Research expects the market for medical devices to experience positive growth in the coming years as new rules and regulations eliminate counterfeit and dangerous products, increasing consumers’ trust and allowing established and reputable vendors to flourish.

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CRISPR/Cas9 U.S. patent board decision appealed

Friday, April 14, 2017

CRISPR Therapeutics, Intellia Therapeutics, Caribou Biosciences and ERS Genomics announced that The Regents of the University of California, the University of Vienna and Dr. Emmanuelle Charpentier (collectively UC), co-owners of foundational intellectual property relating to CRISPR/Cas9 genome engineering, have appealed to the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit) the decision by the Patent Trial and Appeal Board (PTAB) to terminate the interference between certain CRISPR/Cas9 patent claims owned by UC and patents and patent applications owned by the Broad Institute, Harvard University and the Massachusetts Institute of Technology (collectively Broad).

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FDA, Emulate partner on organs-on-chips technology

Wednesday, April 12, 2017

Emulate has entered into a Cooperative Research and Development Agreement (CRADA) with the FDA’s Office of Foods and Veterinary Medicine. Under this multi-year CRADA, Emulate and FDA will collaborate to evaluate and qualify the use of Emulate’s Organs-on-Chips technology as a platform for toxicology testing to meet regulatory evaluation criteria for products—including foods, dietary supplements and cosmetics. The CRADA studies will use Emulate’s Human Emulation System, comprised of Organ-Chips, instrumentation and software apps. The system recreates the natural physiology of specific human tissues and organs, and is designed to provide a predictive model of human response to diseases, medicines, chemicals, and foods with greater precision and detail than other preclinical testing methods, such as cell culture or animal-based experimental testing.

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