In light of indications from FDA that it has put on hold, if not fully abandoned, finalizing its controversial and long-awaited regulatory framework guidance on laboratory-developed tests (LDTs), industry experts say there are other approaches agency could look at to achieve the same or similar objectives.
What's Next For LDTs? FDA May Be Eyeing A New Game Plan
Following the agency's signal to stakeholders that it will not be finalizing a regulatory framework for laboratory-developed tests this year, industry experts suggest some other approaches FDA could take to address lab tests of all stripes.
