A set of rules for IVDs will take effect in 2022, and another for medical devices will take effect in 2020.
Stakeholder input on FDA's draft Rx/Dx codevelopment guidance signals that precision medicine is actually developed differently than the agency wants it to be.
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.
Gene drives might run into biological resistance, the Economist reports.
Forensic experts exhumed painter Salvador Dalí's body to collect DNA for a paternity test, CBS News reports.
Yale Environment 360 writes that synthetic and conservation biologists aren't always on the same wavelength, but they are trying to reach an understanding.
In Science this week: full CRISPR locus integration complex structure, and more.