The US Food and Drug Administration (FDA) issued a final rule classifying in vitro diagnostic devices for the detection of Bacillus anthracis into class II (moderate-risk) with special controls, which means the agency will continue to require a 510(k) premarket notification for the devices.
Gene editing gives researchers a fast, reliable way to make precise changes in specific genes. But its use in farming is in the balance after a European ruling last year equated it with heavily regulated genetic modification.
A World Health Organization (WHO) advisory committee on editing human DNA will ask the United Nations agency to establish a global registry of all such research, recommend that editors of scientific journals not publish any unregistered studies, and ask science funders to require that their grantees register their studies.
Eighteen scientists from seven countries have called for “a global moratorium on all clinical uses of human germline editing” — that is, changing DNA in sperm, eggs, or early embryos to make genetically altered children, alterations that would be passed on to future generations.
In the wake of CRISPR babies, there is an urgent need to better regulate and debate whether, when and how related research should be done.
A newly expanded genetic alphabet that includes four synthetic nucleotides highlights the need for strict boundaries on their use.
The US Food and Drug Administration (FDA) released a revised draft guidance, “Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry,” to support compliance with the intentional adulteration (IA) rule set forth under the FDA Food Safety Modernization Act (FSMA).
The federal government has a short list of regulated organisms. But the government’s ban focuses on the organisms themselves, rather than the genetic instructions for making them. Because the government has not published those sequences, the companies must decide for themselves whether a mail order request is potentially dangerous.
This paper offers an analytical framework is used to assess the risks and benefits of such dual use research, and relevant components of biosecurity policy and the biodefense enterprise (including the acquisition of medical countermeasures) in the United States are discussed.
China is tightening rules on gene-editing, after a Chinese scientist prompted a global outcry by claiming that he had edited the genes of a pair of newborn twins. In a draft regulation released this week, China’s National Health Commission proposed a stringent approval process for biomedical research and heavy penalties for scientists who evade oversight.