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Five Observations from FDA’s Responses to Comments in the Final Rule on LDTs
July 10, 2024| Blog|
Health Law Diagnosed – A Discussion on the Regulatory Requirements for LDTs
March 7, 2024| Podcast|
FDA Faces Critical Deadlines in 2024, Even Without an Election Looming
March 6, 2024| Blog|
2023: Another Year Chock Full of Challenges for FDA
December 20, 2023| Blog|
The LDT Debate: Unpacking Public Responses to FDA’s Proposed Rule
November 20, 2023 | Blog | By Benjamin Zegarelli, David Gilboa
The U.S. Food and Drug Administration (FDA) recently released a proposed rule that would seek to regulate laboratory developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). This rule could reshape the landscape of LDTs and, as expected, has generated substantial attention and feedback from the public, with both supportive and negative comments flooding in. We previously provided a summary of the proposed rule and FDA’s lengthy justification for it here. In this blog post, we will examine some of the key arguments presented in the public comments submitted to Docket FDA-2023-N-2177, as well as public statements published by industry trade associations.
Five Topline Takeaways from FDA’s Proposed Rulemaking on Lab-Developed Tests
October 2, 2023| Blog|
FDA Opens a Pilot Program to Scrutinize Certain Laboratory Developed Tests, But Will It Generate Sufficient Interest?
June 28, 2023 | Blog | By Benjamin Zegarelli
The U.S. Food and Drug Administration (FDA) announced a new pilot program on June 21, 2023 that gives sponsors of oncology products the opportunity to submit validation and performance data for laboratory developed tests (LDTs) intended to support patient selection for such drugs. Although the pilot is limited to only nine participants, it is unclear based on the requirements of the program whether it will generate sufficient interest among oncology product sponsors to meet the objectives that the agency has established for it.
FDA Is Accepting EUA Requests for Monkeypox Tests, But Time is of the Essence
September 28, 2022| Blog|
Summer 2022 Is Here – Do You Know How the FDA User Fee Legislation Is Going?
June 2, 2022| Blog|
FDA Cracks Down on Unauthorized and Counterfeit COVID-19 Diagnostic Tests
May 9, 2022| Blog|
Snapshot of Another Much-Too-Busy Year for FDA Before 2022 Really Gets Started
January 5, 2022| Blog|
FDA Issues Draft Device Guidance in Preparation for the End of the Public Health Emergency
December 27, 2021| Blog|
About Face: Laboratory-Developed Tests for COVID-19 Now Subject to EUA Requirements
November 19, 2021| Blog|
Coverage of FDA’s AI/ML Medical Devices Workshop - Part 3: A Summary of the Panel Discussions
October 20, 2021 | Blog | By Lara Compton, Benjamin Zegarelli
Coverage of FDA’s AI/ML Medical Devices Workshop - Part 2: FDA’s Recent Digital Health Initiatives
October 12, 2021 | Blog | By Benjamin Zegarelli, Lara Compton
FDA and FTC Coordination Appears to Be Escalating
September 15, 2021| Blog|
Biden Administration’s Drug Pricing Plan Calls for Bold Action by Congress
September 10, 2021| Blog|
Ushering in a New Era: FDA Approves First Interchangeable Biosimilar
August 4, 2021| Blog|
HHS Issues Buprenorphine Practice Guidelines as Study Confirms Access Barriers
June 9, 2021 | Blog
FDA’s Unapproved Drugs Initiative Revived, with Gusto!
June 7, 2021| Blog|
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