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Senate proposes greater FDA oversight of Lab Developed Tests
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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...

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FDA issues ambitious new draft guidance to promote clinical trial diversity

On April 14, the U.S. Food and Drug Administration (FDA) released a new draft guidance to industry for increasing racial and ethnic diversity in clinical trials. The draft...

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FDA transition plan for COVID-19 medical devices requests new submissions to agency

On December 22, 2021, the U.S. Food and Drug Administration (FDA) published two draft guidance documents intended to help medical device manufacturers transition out of the temporary rules...

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HHS again permits FDA review of LDTs, updates EUA policy for laboratory developed tests

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) ...

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After a long and winding road, FDA finalizes much-debated “intended use” rule

On August 2, 2021, the U.S. Food and Drug Administration (FDA) published a final rule to amend its “intended use” regulations, codified at 21 CFR § 801.4 for medical...

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First company receives FDA violation notice for ClinicalTrials.gov submission omission

On April 27, 2021, the U.S. Food and Drug Administration (FDA) issued its first Notice of Noncompliance to a company for failing to submit required clinical trial summary results...

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HHS withdraws proposal to exempt 84 medical device types from FDA 510(k) process

On April 16, the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) published a notice of withdrawal of their January 15 proposal to exempt 84 medical ...

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FDA issues new policy for evaluating impact of viral mutations on COVID-19 tests

The U.S. Food and Drug Administration (FDA) has issued new guidance for COVID-19 test developers to evaluate the impact of emerging and future viral mutations on COVID-19 tests. The...

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A step in the right direction: Encouraging diversity in clinical trial populations

On November 9, 2020, the U.S. Food and Drug Administration (FDA) released a final version of its guidance, Enhancing the Diversity of Clinical Trial Populations--Eligibility Criteria,...

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