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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...


FDA expands inspection obstruction guidance to apply to device facilities

The U.S. Food and Drug Administration (FDA) has published the revised draft guidance “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device...


FTC proposes rule to ban nearly all employee non-compete agreements

On 5 January 2023, the Federal Trade Commission (FTC) released a Notice of Proposed Rulemaking (NPRM) for the Non-Compete Clause Rule. The proposed rule, if adopted, would effectively ban...


SEC adopts major Rule 10b5-1 amendments and disclosure requirements relating to securities transactions

On December 14, the SEC adopted long-awaited amendments to Rule 10b5-1 under the Exchange Act that add new conditions for a trading arrangement to qualify for the rule’s affirmative...


New York City delays enforcement of law on artificial intelligence in employment decisions

New York City’s new law concerning artificial intelligence in employment decisions will still go into effect on January 1, 2023, but enforcement has been delayed until April 15, 2023. ...


NYDFS publishes proposed amendments to Cybersecurity Regulation for covered entities

On November 9, 2022, the New York Department of Financial Services (NYDFS) published proposed amendments to significantly expand Cybersecurity Requirements for Financial Services Companies...


FDA explains how to use secondary endpoints in clinical trials to show efficacy

The U.S. Food and Drug Administration (FDA) recently finalized the guidance “Multiple Endpoints in Clinical Trials,” which advises drug sponsors on how to separate analyses of...

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