FDA Gives Guidance on Laboratory Developed Tests

The FDA released what it says is draft guidance that includes a proposed oversight framework for regulating laboratory developed tests (LDTs). The proposed framework is essentially the same as the FDA released to Congress early in its development. As proposed, the agency will continue to exercise “enforcement discretion” over LDTs. Comments are due within 120 days from October 3rd.

Health-Related Hearings and Markups

House Homeland Security Committee will hold a hearing titled “Ebola in the Homeland: The Importance of Effective International Federal State and Local Coordination;” 12:00 p.m. (Central Time Zone), Dallas, TX; October 10.

House Energy and Commerce Oversight and Investigations Subcommittee: will hold a hearing titled “Examining the U.S. Public Health Response to the Ebola Outbreak;” 12:00 p.m., 2123 Rayburn Bldg.; October 16.

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