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
In the third edition of our blog series on decentralized clinical trials (DCTs), we address U.S. Food and Drug Administration’s (FDA) expectations of Sponsors with respect to DTCs as articulated in the recently released draft...more
On January 25, 2019, the Illinois Supreme Court handed down a key ruling that will make it significantly easier for consumers and workers to sue and recover damages for mere non-compliance with the requirements of the state’s...more