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Showing 13 - 24 of 40 results
FDA Regulatory
FDA Faces Critical Deadlines in 2024, Even Without an Election Looming
March 06, 2024 | Blog
Health Care
The LDT Debate: Unpacking Public Responses to FDA’s Proposed Rule
November 20, 2023 | Blog
Health Care
Five Topline Takeaways from FDA’s Proposed Rulemaking on Lab-Developed Tests
October 02, 2023 | Blog
Health Care
FDA Opens a Pilot Program to Scrutinize Certain Laboratory Developed Tests, But Will It Generate Sufficient Interest?
June 28, 2023 | Blog
FDA Regulatory
FDA Is Accepting EUA Requests for Monkeypox Tests, But Time is of the Essence
September 28, 2022 | Blog
FDA Regulatory
Snapshot of Another Much-Too-Busy Year for FDA Before 2022 Really Gets Started
January 05, 2022 | Blog
Health Care
FDA Issues Draft Device Guidance in Preparation for the End of the Public Health Emergency
December 27, 2021 | Blog
Health Care
About Face: Laboratory-Developed Tests for COVID-19 Now Subject to EUA Requirements
November 19, 2021 | Blog
Health Care
The End Is (Somewhat) Nigh: FDA Begins Rolling Back Enforcement Policies Implemented in Response to the COVID-19 Pandemic
November 16, 2021 | Blog