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FDA M-CERSI AI workshop highlights future FDA comment period on AI in drug development

The U.S. Food and Drug Administration (FDA) – in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) – recently...


Strategic financial options for clinical stage life sciences companies in a troubled equity market

Early 2023 has seen new and unprecedented financial challenges for clinical stage life sciences companies. The financing rounds of 2021 and 2022 are starting to run off, while at the same...

Insights and Analysis

U.S. FDA regulatory insights: the seemingly shifting landscape of clinical decision support
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Clinical decision support (CDS) software has lately been a focus of discussion between FDA, industry, and other interested parties. CDS tools assist clinicians by analyzing patient data and ...


U.S. Supreme Court rules high-earning professionals are not overtime-exempt if paid hourly

In an opinion issued on February 22, 2023, the Supreme Court held that high-earning professionals must be paid on a salary basis in order to qualify for overtime exempt status under the...


NLRB purports to limit severance agreements: What this means for employers

On February 21, 2023, the National Labor Relations Board (Board) issued a decision in McLaren Macomb, 372 NLRB No. 58 (Feb. 21, 2023) (Decision), holding that non-disparagement and...


A change of pace: Accelerated Approval reform passed by U.S. Congress

The U.S. Food and Drug Administration (FDA) has several programs available that can expedite the development and regulatory review of a drug or biological product, including Accelerated...


FDA authority to conduct bioresearch monitoring inspections expanded by appropriations legislation

U.S. President Biden recently enacted the “Consolidated Appropriations Act, 2023,” a $1.7 trillion omnibus funding bill that contains the Food and Drug Omnibus Reform Act...


New York City solicits feedback on second set of automated employment decision tool regulations

New York City’s Local Law 144 prohibits employers and employment agencies from using “automated employment decision tools” (AEDTs) to assess hiring and promotion decision...


U.S. Congress embraces FDA’s approach to clinical trial diversity in new Omnibus legislation

In the waning days of 2022, Congress passed the omnibus spending legislation to provide funding for the federal government through September 2023. The legislation contains numerous reforms...

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