On June 4, 2025, the U.S. Department of Health and Human Services Office of Research Integrity (“ORI”) published a Sample Policies and Procedures for Addressing Allegations of Research Misconduct (“Sample Policy”) to align...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
On 12 September 2024, the Office of Research Integrity (ORI) within the US Department of Health and Human Services (HHS) issued a final rule (Final Rule) that significantly modified the standards, procedures, and requirements...more
As the largest public funder of biomedical research in the world, the National Institutes of Health (“NIH”) annually funds over $38 billion in extramural research, including about $6 billion for clinical trials. On May 28,...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
If Sustained, Court Decision Will Require Disclosure of Results for a Decade of Certain Clinical Trials - Section 801 of the Food and Drug Administration Amendments Act of 2007 (“Section 801”), which is codified at 42...more