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Podcast: Talking the cure
11 April 2024
Our team is always thinking about how to foresee and conquer the most significant industry issues facing our clients. In 2020, we launched the podcast "Talking the Cure" where we cover...
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FDA pilots oncology companion diagnostic test/device program as LDT rulemaking nears
18 July 2023
The U.S. Food and Drug Administration recently released the guidance “Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program,” laying out the process...
Insights and Analysis
Senate proposes greater FDA oversight of Lab Developed Tests
31 May 2022
On May 17, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee published a discussion draft of their FDA user fee program reauthorization package, the “Food and...
News
FDA transition plan for COVID-19 medical devices requests new submissions to agency
11 January 2022
On December 22, 2021, the U.S. Food and Drug Administration (FDA) published two draft guidance documents intended to help medical device manufacturers transition out of the temporary rules...
News
HHS again permits FDA review of LDTs, updates EUA policy for laboratory developed tests
22 November 2021
On November 15, the U.S. Department of Health and Human Services (HHS) withdrew a controversial Trump-era HHS Policy Change that effectively prevented the Food and Drug Administration (FDA) ...
News
HHS ends EUA requirement for Laboratory Developed Tests; FDA may continue to assert authority
23 August 2020
On August 19, 2020, the U.S. Department of Health and Human Services (HHS) announced the rescission of guidances and other Food and Drug Administration (FDA) issuances concerning premarket...
News
FDA’s revised COVID-19 test kit policy requires EUAs for serology tests
05 May 2020
On May 4, 2020, the U.S. Food and Drug Administration (FDA) updated its policy on COVID-19 test kits, which was originally published on March 16, 2020. In particular, the revised...
Insights and Analysis
Diagnostics regulation reform proposals move forward again with an updated VALID Act
10 March 2020
The updated, bipartisan Verifying Accurate, Leading-edge IVCT Development Act (VALID Act), creates a regulatory framework for a new product paradigm called in vitro clinical tests (IVCTs),...
News
Genetic tests and medication response: FDA announces collaborative review of scientific evidence
27 February 2020
FDA announced the introduction of a collaboration between the Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and Research (CDER) to provide the...
