The Food and Drug Administration has announced plans to begin regulating Laboratory Developed Tests (LDTs) to ensure that tests used to diagnose thousands of diseases and other conditions are reliable and accurate. In light of this important announcement, Q1 Productions has added a brand new session to the agenda for the 5th Annual Clinical Affairs & Regulatory Approvals For Diagnostics Conference that highlights the major components of this proposal and will allow attendees to gain exclusive FDA perspective on this regulation. Check out the session abstract below:
FDA REVIEW OF LAB DEVELOPED TEST DRAFT GUIDANCE
As LDTs become increasingly complex and the laboratory setting progressively large-scale, the FDA has announced it would start regulating lab developed tests and in particular, tests that are used to make important treatment decisions so that they can be vetted and validated before use. With no short of varying opinions on the proposed regulation, the FDA has claimed legal authority to regulate LDTs and as such, congress has required the agency to release publication of the draft guidance by September 30th, 2014. Through FDA advisory, attendees will walk through the draft guidance and gain exclusive FDA perspective on the proposed regulation further understanding how it might impact clinical and regulatory strategy followed by open questions and comments.
Registration is open for 5th Annual Clinical Affairs & Regulatory Approvals For Diagnostics Conference; visit www.q1productions.com/ivd-regulatory or contact marketing@q1productions.com for more details.
