(1) Laboratory Developed Tests; (2) Limitations on Sharing Data with China and Other Countries of Concern

Abstract:

Laboratory Developed Tests

The scope of FDA’s authority over laboratory-developed tests (“LDTs”) has long been a source of controversy and debate among government and industry stakeholders. In May 2024, FDA issued a final rule that affirms FDA’s position that LDTs are in vitro diagnostic products (“IVDs”) regulated as medical devices under the Federal Food, Drug, and Cosmetic Act (“FDCA”). In conjunction with this rule, FDA intends to phase out the enforcement discretion policy it has historically applied to most LDTs. This session will summarize the FDA’s final rule and phaseout policy, analyze the impact on clinical research (including the use of LDTs in pharmaceutical trials), and assess the prospects for ongoing litigation challenging FDA’s rule and potential LDT-related legislation from Congress.

Limitations on Sharing Data with China and Other Countries of Concern

Over the past several months there have been significant U.S. executive and congressional actions related to restricting transactions, data transfers, and certain types of contracts with China, other countries of concern (e.g., Russia), and individuals and businesses connected with these countries. Principally, this includes the enactment in April 2024 of the Protecting Americans’ Data from Foreign Adversaries Act, President Biden’s Executive Order on bulk sensitive personal data transfers and the accompanying U.S. Department of Justice rulemaking activities, and the continued consideration by Congress of the BIOSECURE Act. In this session, we will walk through these different pieces of legislation and proposed regulations, focusing on the implications they each may hold for the clinical research enterprise.

This is a meeting of The Research, Development, and Regulatory Roundtable (R3) and is open to sponsors. Click here to learn more about the Research, Development, and Regulatory Roundtable (R3) and how to become a sponsor.

Topic: (1) Laboratory Developed Tests; (2) Limitations on Sharing Data with China and Other Countries of Concern