Publications

News

Senate bill proposes laboratory developed tests to be regulated under CLIA process

U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the...

News

In midst of COVID-19, FDA reminds industry that it plays both good and bad cop

U.S. authorities are actively policing entities making illegal promotional claims that products mitigate, prevent, treat, cure, or diagnose COVID-19. To date, seven Warning Letters...

News

COVID-19’s impact on clinical trials prompts FDA to issue guidance to assist with study conduct
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On Wednesday, March 18, the U.S. Food and Drug Administration published the guidance“Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic." The guidance...

News

The global impact of COVID-19 on clinical trials and countermeasure development
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The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of...

Insights

Diagnostics regulation reform proposals move forward again with an updated VALID Act
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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),...

Insights

Variable De Novo review metrics -- Plan ahead
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Recent data from the U.S. Food and Drug Administration (FDA or the agency) on the percentage of De Novo classification requests that are declined or withdrawn raises questions about the...

News

Pilot program for 510(k) electronic submissions is requesting participants

The U.S. Food and Drug Administration (FDA) announced that it is soliciting participation in a voluntary pilot program for streamlining electronic submissions for 510(k) premarket...

News

Genetic tests and medication response: FDA announces collaborative review of scientific evidence

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...

Insights

Management of large liabilities of health care companies through bankruptcy
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Two recent decisions involving health care companies demonstrate how reorganization under Chapter 11 of the Bankruptcy Code [1] can be used to manage large liabilities.

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