A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and set aside, in its entirety, the U.S. Food and Drug Administration’s (FDA) Final Rule titled Medical...more
4/3/2025
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Medical Devices ,
Regulatory Authority ,
Regulatory Requirements ,
Vacated
On October 2, 2024, the U.S. Food and Drug Administration (FDA) released guidance in a question and answer format regarding the use of electronic systems, electronic records, and electronic signatures in clinical...more
11/21/2024
/ Abbreviated New Drug Application (ANDA) ,
Cloud Computing ,
Corrective Actions ,
Data Collection ,
Data Management ,
Data Security ,
Electronic Protected Health Information (ePHI) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Information Technology ,
Policies and Procedures ,
Record Retention
On September 17, 2024, the Office of Research Integrity (ORI) issued a final rule adopting changes to federal regulations governing research misconduct involving federally funded research (Final Rule). The regulations have...more
9/25/2024
/ Appeals ,
Confidential Information ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Documentation ,
False Claims Act (FCA) ,
Final Rules ,
Fraud ,
HHS Office of Research Integrity (ORI) ,
Investigations ,
New Regulations ,
Plagiarism ,
Public Health Service (PHS) ,
Statute of Limitations ,
Transcripts ,
Willful Misconduct