regulatory guidance | GenomeWeb

regulatory guidance

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.

NIH Director Francis Collins; FDA Commissioner Robert Califf

With NIH funds, organizations will build the 1 million volunteer cohort, while FDA's draft guidances will inform regulation of genetic tests critical for precision medicine.

FDA's David Litwack said at the Festival of Genomics that the agency will soon release a draft document laying out a regulatory proposal for public comment.

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