The U.S. Drug Enforcement Administration (DEA) is on the brink of reclassifying marijuana, marking a watershed moment in American drug policy. For decades, marijuana has been classified as a Schedule I drug, alongside...more
The U.S. Senate and the U.S. House of Representatives are both considering legislation that could have a serious impact on the ability of U.S. biotechnology, drug, and medical device companies to do business with...more
3/19/2024
/ Artificial Intelligence ,
Biosimilars ,
Biotechnology ,
China ,
Department of Homeland Security (DHS) ,
Life Sciences ,
Medical Devices ,
National Security ,
OMB ,
Pharmaceutical Industry ,
Popular ,
Risk Assessment
The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more
3/11/2021
/ 21st Century Cures Act ,
Artificial Intelligence ,
Center for Drug Evaluation and Research (CDER) ,
Compliance ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Diagnostic Tests ,
Digital Health ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Machine Learning ,
Maintenance ,
Medical Devices ,
Personal Protective Equipment ,
Popular ,
Technology ,
Third-Party Service Provider
Recognizing the impact of the COVID-19 pandemic on the conduct of clinical trials for drugs and medical devices, on March 18, the Food and Drug Administration (FDA) issued a guidance without prior public comment that is...more