regulatory guidance | GenomeWeb

regulatory guidance

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. 

Lab professionals have criticized FDA's analytical performance recommendations for germline NGS tests as needlessly strict and evidence of why it shouldn't regulate LDTs.

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In Nucleic Acids Research this week: nanopore sequencing workflow to detect antibiotic resistance in gut microbes, TSSPlant tool, and more.

Because gene-edited organisms can cross borders, Gizmodo wonders whether there should be an international body to govern their use.

HHS Secretary nominee Tom Price is to go in front of the Senate Committee on Health, Education, Labor and Pensions today, NPR's Morning Edition reports.

Prior to being closed, Theranos' Arizona lab failed an inspection by regulators, according to the Wall Street Journal.