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Your search for ‘Arnall Golden Gregory’ returned 73 results

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  • Article

    Analysis Of Recent OIG Advisory Opinion On Employment Of Excluded Individuals

    The Department of Health and Human Services, Office of Inspector General (OIG) recently released a favorable advisory opinion, OIG Advisory Opinion No. 22-11 (the "Opinion"), analyzing...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Arnall Golden Gregory
    Arnall Golden Gregory
  • Article

    Break On Through To The Other Side, Part 2: FDA Issues Draft Guidance About Breakthrough Therapy Designation Rescission

    In September 2014, AGG prepared a Bulletin on the Food and Drug Administration's Breakthrough Therapy Designation (BTD) program, referencing The Doors' "Break On Through to the Other Side."
    United StatesFood, Drugs, Healthcare, Life Sciences
Arnall Golden Gregory
Arnall Golden Gregory
  • Article

    Georgia Enacts New Background Check Legislation For Long-Term Care Providers

    Georgia has enacted a new law implementing a comprehensive program of background checks for Georgia long-term care facilities.
    United StatesEmployment and HR
    Arnall Golden Gregory
    Arnall Golden Gregory
  • Article

    CMS Releases Skilled Nursing CHOW (And Ownership) Data

    For the first time, the Centers for Medicare & Medicaid Services (CMS) has released data publicly on skilled nursing facility changes of ownership (CHOWs)).
    United StatesFood, Drugs, Healthcare, Life Sciences
    Arnall Golden Gregory
    Arnall Golden Gregory
  • Article

    The Pitch - January 2022

    The Pitch newsletter is a monthly update of legal issues and news affecting or related to the music, film and television, fine arts, media, professional athletics, eSports, and gaming industries.
    United StatesMedia, Telecoms, IT, Entertainment
    Arnall Golden Gregory
    Arnall Golden Gregory
  • Article

    You Cannot Do It Any Way You Want It: FDA Issues An Untitled Letter For An Incomplete Journey Forward

    Late last year, the Food and Drug Administration's Office of Prescription Drug Promotion issued an Untitled Letter to a drug company for unlawful promotion of its biologic product.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Arnall Golden Gregory
    Arnall Golden Gregory
  • Article

    The Pitch - February 2022

    The Pitch newsletter is a monthly update of legal issues and news affecting or related to the music, film and television, fine arts, media, professional athletics, eSports, and gaming industries.
    United StatesMedia, Telecoms, IT, Entertainment
    Arnall Golden Gregory
    Arnall Golden Gregory
  • Article

    Out Of Touch: FDA Takes Exception With Drug Company's Promotion For Topical Drug Product

    Who doesn't remember Hall and Oates' 1984 hit, "Out of Touch?" Perhaps, reviewers in the Food and Drug Administration's Office of Prescription Drug Promotion were humming this song...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Arnall Golden Gregory
    Arnall Golden Gregory
  • Article

    Delaware Bankruptcy Court Decision Highlights Potential Defenses To Equitable Subordination Claim

    On March 25, 2022, the United States Bankruptcy Court for the District of Delaware dismissed a complaint filed against a lender and other entities.
    United StatesInsolvency/Bankruptcy/Re-Structuring
    Arnall Golden Gregory
    Arnall Golden Gregory
  • Article

    Freeze-Frame: FDA Issues An Untitled Letter For An Unlawful Instagram Post

    Does anyone remember the 1980's song, "Freeze-Frame" by The J. Geils Band? A new year, a new Untitled Letter issued by the FDA's Office of Prescription Drug Promotion to a prescription drug company.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Arnall Golden Gregory
    Arnall Golden Gregory
  • Article

    Kentucky Rewrites Its Assisted Living Law

    In keeping with several states that have recently overhauled their assisted living laws, the Commonwealth of Kentucky has enacted sweeping changes to its regulatory framework for...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Arnall Golden Gregory
    Arnall Golden Gregory
  • Article

    Industry News - January 28, 2022

    AGG's Restructuring Roundup newsletter is a monthly update of legal issues and news affecting or related to commercial litigation and bankruptcy.
    GlobalInsolvency/Bankruptcy/Re-Structuring
    Arnall Golden Gregory
    Arnall Golden Gregory
  • Article

    A Change Is Gonna Come: AdvaMed Revises Its Code Of Ethics On Interactions With Health Care Professionals

    In 1964, Sam Cooke sang "A Change is Gonna Come." In March 2022, the Advanced Medical Technology (AdvaMed) said the same when it announced revisions to its...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Arnall Golden Gregory
    Arnall Golden Gregory
  • Article

    Upcoming Annual Deadline For HIPAA Small Breach Reporting: March 1, 2022

    HIPAA-covered entities should note the quickly approaching March 1, 2022 deadline for reporting breaches of unsecured protected health information that occurred in 2021 and involved fewer than 500 individuals.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Arnall Golden Gregory
    Arnall Golden Gregory
  • Article

    Russia Sanctions: What Global Business Needs To Know Now

    This is a fast-moving issue and additional sanctions are possible at any time.
    GlobalInternational Law
    Arnall Golden Gregory
    Arnall Golden Gregory
  • Article

    Roll With The Changes: FDA's Proposed Amendments To Converge Its Quality Management System Requirements With ISO Requirements

    In the words of the rock band REO Speedwagon, from the 1978 song "Roll with the Changes," "It had to happen, felt the tables turnin'." Earlier this month, the Food and Drug Administration's Device Good...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Arnall Golden Gregory
    Arnall Golden Gregory
  • Article

    Do You Get To Keep Your Roth IRA Even If You File Bankruptcy? In Georgia, Yes, Says The Eleventh Circuit

    In Hoffman, the debtor was a retired Air Force Colonel who had personally guaranteed a large SBA loan that his son-in-law used to operate a restaurant.
    United StatesInsolvency/Bankruptcy/Re-Structuring
    Arnall Golden Gregory
    Arnall Golden Gregory
  • Article

    The Consequences Of The Shifting Landscape In Opioid-Related Litigation

    The end of 2021 was marked by several significant developments in the wave of litigation that has resulted from the opioid crisis of the last several years.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Arnall Golden Gregory
    Arnall Golden Gregory
  • Article

    Supreme Court Issues Split Decisions On Federal Vaccine Mandates

    On January 13, 2022, the U.S. Supreme Court issued split decisions regarding Federal vaccine mandates issued by the Centers for Medicare and Medicaid Services and the Occupational Safety and Health Administration.
    United StatesCoronavirus (COVID-19)
    Arnall Golden Gregory
    Arnall Golden Gregory
  • Article

    Looking Back To See What The Future Holds For Cybersecurity Enforcement

    The year 2021 will likely be seen as a defining moment in the history of cybersecurity enforcement.
    United StatesTechnology
    Arnall Golden Gregory
    Arnall Golden Gregory
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