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Funded reinsurance comes under the regulatory spotlight

The increasing use of innovative and complex “funded” or “asset-intensive” reinsurance structures by life insurance companies, fuelled in particular by the unabated...

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New FDA clinical trials guidances promote efficient drug development, innovative designs, diversity

The U.S. Food and Drug Administration (FDA) issued this week three guidance documents related to clinical trials: a draft guidance on multiregional trials in oncology, a draft guidance on...

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Mandatory compliance nears for remaining Section 13 reporting requirements

The last two mandatory compliance dates under the SEC’s amendments to Exchange Act Regulation 13D-G adopted in October 2023 are fast approaching. We discussed the amendments in our SEC...

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SEC, whistleblowers and impact on employment-related agreements

On September 9, 2024, the U.S. Securities and Exchange Commission announced it had settled charges against seven public companies that utilized employment and employment-related agreements...

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FDA promotes pre-approval for changes to devices, LDTs via PCCPs

The U.S. Food and Drug Administration (FDA) has published new draft guidance on “Predetermined Change Control Plans for Medical Devices,” which describes the process by which...

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FDA publishes long-awaited clinical trial diversity guidance

The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations ...

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FDA publishes long-awaited clinical trial diversity guidance

The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations ...

News

Recent developments in FCA enforcement under the DOJ’s Civil Cyber-Fraud Initiative

Over the last six months, the U.S. Department of Justice (DOJ) has remained vigilant in pursuing cybersecurity-related fraud under its Civil Cyber-Fraud Initiative first announced in...

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FDA summarizes LDT rule requirements in new compliance guide

The U.S. Food and Drug Administration (FDA) announced yesterday a “Small Entity Compliance Guide” (SECG) for Laboratory Developed Tests (LDTs), aiming to assist small...

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