Fewer than one-in-10 countries have met global standards for securing high-consequence pathogens, increasing risks of an accidental disease outbreak or bioterrorism, a campaign group has warned. Just 19 countries completing a United Nations safety check have built or shown strong biosecurity safeguards.
The Committee on Foreign Investment in the United States (CFIUS) recently broadened its coverage of biotechnology transactions via new regulations that became effective on November 10, 2018.
This plan provides an overview of priorities the US Food and Drug Administration (FDA) will pursue to support innovation in plant and animal biotechnology and to advance the agency’s public health mission.
The new plan advances policy priorities that the US Food and Drug Administration (FDA) will pursue to clarify their science-and-risk-based approach for product developers; avoid unnecessary barriers to future innovation in plant and animal biotechnology; and advance safety.
Six companies and institutions were punished by the Ministry of Science and Technology due to breaching regulations on the management of human genetic resources.
A crucial part of the arsenal for shaping the future of gene editing is hiding in plain sight: the patent system. In the past, patents have played an important part in regulating new technologies and research.
The technology and economics of large-scale DNA synthesis have driven the cost of gene synthesis down approximately 250-fold in just 10 years. The World Health Organization’s (WHO) guidelines relating to variola virus are also unknown to most biologists.
Japan has issued draft guidelines that allow the use of gene-editing tools in human embryos.
Existing Australian regulation within the Gene Technology Act does address many of the concerns likely to arise in synthetic biology.
The Trump administration wants to modernize the federal guidelines for companies that sell made-to-order DNA in hopes of keeping dangerous genetic material out of the hands of malicious potential customers.