The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
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On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....more
On June 26, 2024, FDA issued a new draft guidance on clinical trial diversity, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (Draft Guidance), to assist...more
The U.S. Food and Drug Administration (FDA) issued a long-anticipated draft guidance on June 26, 2024, entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more
On September 29, 2023, the Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule is open for public comment through...more
Throughout August 2023, the Office of Information and Regulatory Affairs, Office of Management and Budget, Executive Office of the President (“OIRA”) has held stakeholder meetings regarding a proposed rule which, if enacted,...more
This post is the first in a series of three in which we recap the Food and Drug Administration’s somewhat difficult year, having spent the majority of it without a permanent Commissioner and facing a slew of political and...more
On January 13, 2017, the US Food and Drug Administration (FDA) posted a “discussion paper” in which the agency outlines a substantially revised “possible approach” to the oversight of laboratory-developed tests (LDTs). The...more
Following its recent announcement that it would not finalize its 2014 draft guidance on laboratory developed tests (“LDTs”), the U.S. Food and Drug Administration (“FDA”) issued a Discussion Paper on Laboratory Developed...more
The U.S. Food and Drug Administration (FDA) issued today a Discussion Paper on Laboratory Tests (LDTs). The Discussion Paper follows draft guidance issued by the FDA in 2014 (2014 Draft Guidance) and a stakeholder workshop...more
Last week the Food and Drug Administration (FDA) decided to delay finalizing draft guidance for Laboratory Developed Tests (LDT). First issued in July of 2014, the draft guidance would give FDA regulatory oversight of LDTs. ...more
The two draft guidance documents are intended to streamline the review of next generation sequencing-based tests. On July 8, the US Food and Drug Administration (FDA or Agency) issued two draft guidance documents...more
Health care practitioners are more frequently using laboratory developed tests (LDTs) to diagnose and predict the risk of developing a disease, as well as to inform decisions on disease state management such as for cancer,...more
On Friday, October 31, 2014, FDA posted on its website an audio recording, transcript, and slides from its October 23, 2014 webinar discussing the draft guidance document titled “Framework for Regulatory Oversight of...more
On September 30th, 2014 the U.S. Food and Drug Administration published the draft guidance entitled ”Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (“Guidance”). The publication of the draft Guidance...more
At a contentious hearing of the House Energy and Commerce Health Subcommittee on September 9, 2014, lawmakers and the Food and Drug Administration (FDA) clashed over proposed guidance from the FDA regarding the regulation of...more
Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that...more
FDA sends notice to Congress on LDTs. The U.S. Food and Drug Administration (FDA) has notified Congress that it intends to issue draft guidance to propose a risk-based, phased-in framework for oversight of laboratory...more