Drug Development for NASH with Fibrosis: Expedited Programs
Posted 30th July 2021 by Nicholas Noakes
George Makar spoke at the Global NASH Congress. He gave a regulatory perspective on Drug Development for NASH with Fibrosis. The views were his own. In part one, we explore expedited programs.
A new kind of pheromone to control agricultural pests
Posted 5th August 2019 by Jane Williams
Karl Cameron Schiller is co-founder of Pheronym, a Davis-based agriculture biotech start-up using a new kind of pheromone from microscopic roundworms called nematodes to control agricultural pests. We asked him about his work.
Navigating the regulatory landscape for agricultural products
Posted 31st July 2019 by Jane Williams
Terry Stone has worked in agricultural products for almost 30 years and has experience in both research and regulatory affairs. He is currently President, TB Stone Solutions. He was previously Vice President of Regulatory Affairs and Sustainability Programs for Agrinos, where he worked with industry associations in the US and the EU to develop a regulatory framework for plant biostimulants. We spoke to him about his work.
The benefits of lysates vs live probiotic cultures in skincare
Posted 12th July 2019 by Jane Williams
Numerous skincare brands incorporate lysates in their formulas. However, few brands are able to harness live and active bacteria in addition to the lysates. Neither is an easy task when it comes to formulation however, we can all acknowledge and appreciate the difficulty in working with live probiotics. So, what are the benefits and is this extra challenge worth the effort?
Positive Regulatory Developments for the U.S. Ag Tech Industry
Posted 3rd July 2019 by Jane Williams
2019 may prove to be propitious in terms of meaningful improvements to the regulatory strictures facing agricultural biotech and biologically based products.
In a move that will hopefully lead to positive changes in the regulatory situation facing ag biotech products, on June 11, 2019, President Trump signed an Executive Order directing the heads of the U.S. Department of Agriculture (USDA), Environmental Protection Agency (EPA), and Food and Drug Administration (FDA) to take specific steps to streamline and improve the regulatory processes applicable to the products of agricultural biotechnology.
A global perspective on the developments in biotech regulations
Posted 28th June 2019 by Jane Williams
The ECJ ruling on GMOs has raised pertinent issues. How will it impact on current and future research? What are the optimum routes to progressing plant research?
In light of the ruling, it was a good time to welcome experts in policy and regulatory affairs to the recent 7th Plant Genomics & Gene Editing Congress: Europe to explore these issues. We’re lucky to be able to share this presentation from the event for those that weren’t able to make it. Watch it here.
The Top 5 Plant Genomics Articles of 2018
Posted 26th December 2018 by Jane Williams
It has been an eventful year for plant genomics: we’ve seen advancements in plant disease research, the sequencing of the wheat genome, which was finally achieved through a worldwide collaboration of researchers spanning 13 years, and the ruling on the legal status of gene-edited crops.
As 2018 draws to a close, we thought it was a good time to reflect. Here, we’ve collated our top articles of the year.
EU Court of Justice Rules that Gene Edited Organisms will be Regulated as GMOs
Posted 22nd August 2018 by Jane Williams
On 25 July 2018, the Court of Justice of the European Union, the EU’s highest court, issued a decision clarifying whether the EU would regulate products of innovative breeding techniques, like gene editing, under the EU’s Directive 2001/18, the principal EU law governing the regulation of GMOs.