Michael Darling

Skadden, Arps, Slate, Meagher & Flom LLP

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Key Questions Remain Despite FDA Attempts To Clarify Guidance on Clinical Decision Software

Clinical decision support (CDS) software has been recognized — including by government agencies — as having significant potential to increase quality of care and enhance health outcomes, and companies across the health care...more

1/31/2023 / Enforcement , Federal Food Drug and Cosmetic Act (FFDCA) , Final Guidance , Food and Drug Administration (FDA) , Government Agencies , Healthcare , Healthcare Workers , International Medical Device Regulators Forum (IMDRF) , Software

OFAC and FinCEN Announce First Parallel Enforcement Actions in the Virtual Currency Space

On October 11, 2022, the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) and the Financial Crimes Enforcement Network (FinCEN) announced settlements for approximately $24 million and $29 million,...more

11/16/2022 / Bank Secrecy Act , Cryptocurrency , Enforcement Actions , FinCEN , Office of Foreign Assets Control (OFAC) , Suspicious Activity Reports (SARs) , Virtual Currency

Revisions to the DOJ’s Corporate Criminal Enforcement Policy Will Require Companies To Reevaluate Their Compliance Systems

In a recently published memorandum, Deputy Attorney General (DAG) Lisa Monaco announced important updates to the U.S. Department of Justice’s (DOJ’s) approach to investigating and prosecuting corporate crimes. In the...more

10/14/2022 / Compliance , Corporate Crimes , Criminal Investigations , Criminal Prosecution , Department of Justice (DOJ) , Enforcement Actions , FCPA Corporate Enforcement Policy (CEP) , FCPA Guidance , Foreign Corrupt Practices Act (FCPA) , White Collar Crimes

FDA Proposes Amendments to Medical Device Quality System Regulation

On February 22, 2022, the Food and Drug Administration (FDA) proposed a long-awaited rule to amend its Quality System Regulation (QSR), which is codified at 21 CFR Part 820 and sets forth current good manufacturing practice...more

3/2/2022 / CGMP , Comment Period , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Proposed Rules , Public Comment , Regulatory Standards , Rulemaking Process

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