Navigating the complexities of maintaining a stable supply chain in an ever-changing global environment is a key focus for FDA-regulated companies. As US policy shifts, the topic of global supply chain has only become more...more
On June 26, 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance setting forth detailed requirements for the submission of Diversity Action Plans (DAPs) by sponsors of certain clinical studies involving...more
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
On May 10, the U.S. Food and Drug Administration (FDA) published a discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products.” The paper is a collaboration between...more
5/15/2023
/ Artificial Intelligence ,
Biologics ,
Center for Biologics Evaluation and Research (CBER) ,
Center for Drug Evaluation and Research (CDER) ,
Discussion Draft ,
Food and Drug Administration (FDA) ,
GAO ,
Life Sciences ,
Machine Learning ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Research and Development
On Jan. 23, the Food and Drug Administration (FDA) finalized industry guidance for clinical research using cannabis and cannabis-derived compounds, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical...more
1/30/2023
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Clinical Trials ,
Controlled Substances Act ,
DEA ,
Farm Bill ,
Food and Drug Administration (FDA) ,
Hemp ,
Investigational New Drug Application (IND) ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
THC