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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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Update

COVID-19: Tracker for SEC and related developments for U.S. public companies

This quick-reference guide briefly summarizes recent regulatory developments from the SEC, NYSE, and Nasdaq in response to the COVID-19 pandemic and certain other COVID-19-related...

News

U.S. Supreme Court rejects categorical rule that generic term plus “.com” results in a generic composite

The United States Supreme Court holds that adding a top-level domain, like “.com”, to an otherwise generic term does not automatically result in a generic composite, and that a...

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

Crypto firm co-founder pleads guilty for $25 million ICO fraud scheme

The U.S. Department of Justice (DoJ) has announced that the co-founder of a cryptocurrency company who misled victims into investing $25 million in a fraudulent scheme has pled guilty for...

News

Medicaid Drug Rebate Program proposed rule on value-based pricing, line extension, PBM accumulators

On June 17, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a Proposed Rule (link) that would materially modify current Medicaid Drug Rebate Program (MDRP) regulations....

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...

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