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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

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News

FDA quietly withdraws plans for a Devices Referencing Drugs regulatory approval pathway

The U.S. Food and Drug Administration recently withdrew its plans for a “Devices Referencing Drugs” (DRD) regulatory approval pathway, which it had proposed in September 2017....

News

FDA updates FAQ on COVID-19 tests and validation

Last week, on 23-25 June 2020, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) updated the responses to six of the Frequently Asked Questions...

News

COVID-19: Daily Report for Life Sciences and Health Care Companies

The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the worldto helplife sciences and health care companies stay current in this challenging...

News

COVID-19 update: Facilitating diagnostic test availability for asymptomatic testing, sample pooling

On June 16, the U.S. Food and Drug Administration (FDA) posted updates to their Molecular Diagnostic Templates for developers that intend their assay to be used for pooled patient samples...

News

COVID-19: Daily Report for Life Sciences and Health Care Companies (22 - 26 June 2020)

The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the worldto helplife sciences and health care companies stay current in this challenging...

News

USPTO Alert – New fast track for certain COVID-19 trademark applications

The United States Patent & Trademark Office (“USPTO”) announces a new prioritized trademark examination program for certain trademark applications covering COVID-19 related...

News

COVID-19: Daily Report for Life Sciences and Health Care Companies (15 - 19 June 2020)

The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the worldto helplife sciences and health care companies stay current in this challenging...

News

COVID-19: Daily Report for Life Sciences and Health Care Companies (15 - 19 June 2020)

The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the worldto helplife sciences and health care companies stay current in this challenging...

News

FDA revises EUA guidance for mask & respirator decontamination and bioburden reduction systems

On May 26, 2020, the U.S. Food and Drug Administration (“FDA” or “Agency”) issued an immediately in effect guidance, Recommendations for Sponsors Requesting EUAs for ...

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