regulatory guidance | GenomeWeb

regulatory guidance

The agency is looking for information on potential food safety risks and whether new regulations are needed for genome-edited plants.

The FDA approved a slew of new drugs with companion and complementary tests, but the most talked about event was its decision to delay final guidance on LDTs.

The annual list includes guidelines that would clarify regulations for garnering premarket approval or clearance of devices and diagnostics, particularly next-generation sequencing tests.

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.

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.

By outlining a framework for advancing a drug and test together, the agency said it hopes to encourage innovations in precision medicine.

The agency has outlined a process for recognizing public genetic variant databases, but industry players say the field lacks incentives to advance such resources. 

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A Karmagenes researcher has lost his position after reportedly admitting to data fabrication, according to Retraction Watch.

Two neuroscientists write in Nature News that solving the "reproducibility crisis" in science may require changing the requirements for publication.

In Nature this week: genomic analysis of prehistoric New Mexicans, a nanopore method for mapping DNA methylation, and more.

A new study finds that adding missing good bacteria to the skin microbiome of atopic dermatitis patients decreases Staphylococcus aureus colonization.