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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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COVID-19 Report for Life Sciences and Health Care Companies

The COVID-19 Report is a compilation of coronavirusnews, analysis, and insightsfrom around the worldto helplife sciences and health care companies stay current in...

News

FDA takes action to reduce surgical mask shortage

To address the increased usage and shortages of surgical masks as a result of combatting COVID-19, on August 5, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use...

News

COVID-19 Report for Life Sciences and Health Care Companies (3 - 7 August 2020)

The COVID-19 Report is a compilation of coronavirusnews, analysis, and insightsfrom around the worldto helplife sciences and health care companies stay current in...

News

FDA finalizes policy on multi-function medical devices’ premarket submissions

On July 28, the U.S. Food and Drug Administration (FDA) issued the final guidance “Multiple Function Device Products: Policy and Considerations,” which describes FDA's...

News

FDA authorizes first diagnostic test for screening people without known or suspected COVID-19 infection

On July 24, 2020, the U.S. Food and Drug Administration (FDA) reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use: (1) testing ...

News

COVID-19 Report for Life Sciences and Health Care Companies (27 - 31 July 2020)

The COVID-19 Report is a compilation of coronavirusnews, analysis, and insightsfrom around the worldto helplife sciences and health care companies stay current in...

News

FDA releases enforcement policy for VTM and PBS/saline transport media during the COVID-19 pandemic

On July 21, 2020, the U.S. Food and Drug Administration (FDA) issued an immediately in effect enforcement policy guidance to help facilitate the availability of devices used in transporting ...

News

COVID-19 Report for Life Sciences and Health Care Companies (20 - 24 July 2020)

The COVID-19 Report is a compilation of coronavirusnews, analysis, and insightsfrom around the worldto helplife sciences and health care companies stay current in...

News

FDA extends enforcement discretion period for regenerative medicines, citing COVID-19 challenges

Today, the U.S. Food and Drug Administration (FDA) extended the enforcement discretion period for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps) by an...

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