Glorikian's new book offers guidance for companies looking to develop in vitro diagnostics, on everything from determining value to getting reimbursement.
At the Personalized Medicine World Conference, stakeholders and the former FDA commissioner discussed how regulation can advance personalized medicine amid political uncertainty.
The white paper, while not enforceable, addresses the lab industry's concerns and makes a public health case for FDA oversight of LDTs.
The guidance may be dead, but the issues underlying the controversy aren't, according to Gibbs, who said the agency can still take enforcement action against specific tests.
According to multiple sources in Washington, DC, the FDA has been informing stakeholders in policy circles of the decision.
During an FDA-sponsored workshop last week, participants discussed ideas for a regulatory framework that can evolve with rapidly advancing technology.
The committee questioned stakeholders about the impact of FDA oversight of LDTs, and whether there was any consensus about how to move forward on a divisive topic.
The institute announced ECRIgene this June, and is now offering it to paying subscribers from the clinical, regulatory, reimbursement, and test development spheres.
Despite a negative initial reaction to the guidelines from some stakeholders, the agency wants feedback on the draft proposals and will hold another workshop to discuss them.
Responding to initial criticism of the draft guidelines on NGS testing, Mansfield emphasized that the documents are not final and assured that the agency will continue to listen to stakeholders.
In Science this week: genetic target for urothelial bladder cancer treatment, and more.
At the Conversation, the University of Oxford's Michael Macklay writes that learning genetic risk of disease is a personal decision.
Two dozen scientific organizations have endorsed the March for Science, according to ScienceInsider.
Researchers in Japan describe a chimpanzee with a chromosomal abnormality similar to human Down syndrome, Mashable reports.