On June 26, 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance setting forth detailed requirements for the submission of Diversity Action Plans (DAPs) by sponsors of certain clinical studies involving...more
As we approach the conclusion of another transformative year, we are excited to present our comprehensive year-end review, shedding light on the trends shaping the healthcare market in 2023. Our team’s keen insights and...more
1/19/2024
/ Antitrust Litigation ,
Artificial Intelligence ,
Biotechnology ,
Cannabis Products ,
Centers for Medicare & Medicaid Services (CMS) ,
Complex Corporate Transactions ,
Coronavirus/COVID-19 ,
Corporate Transparency Act ,
Electronic Protected Health Information (ePHI) ,
False Claims Act (FCA) ,
Health Care Providers ,
Hospitals ,
Information Blocking Rules ,
Medical Research ,
Medicare ,
PHI ,
Private Equity ,
Recovery Audit Contractors (RACs) ,
Regulatory Oversight ,
Section 340B ,
SNF ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
Concerns have grown tremendously in recent years regarding noncompliance in clinical trial reporting. Shockingly, the National Institutes of Health (NIH) failed to disclose the results of over one-third of the clinical trials...more
8/23/2023
/ Clinical Trials ,
Compliance ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Medical Research ,
National Institute of Health (NIH) ,
OIG ,
Pharmaceutical Industry ,
Registration Requirement ,
Reporting Requirements ,
Sponsors
On Aug. 15, the Food and Drug Administration (FDA) issued new guidance aimed at assisting institutional review boards (IRBs), clinical investigators and sponsors in complying with the FDA’s informed consent requirements for...more