On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more
10/4/2022
/ 21st Century Cures Act ,
Clinical Trials ,
Consent ,
Department of Health and Human Services (HHS) ,
Federal Register ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Investigational Device Exemptions ,
Investigational New Drug Application (IND) ,
National Institute of Health (NIH) ,
New Guidance ,
Notice of Proposed Rulemaking (NOPR) ,
Office for Human Research Protections (OHRP) ,
Recordkeeping Requirements ,
The Common Rule ,
Waivers
On April 16, 2021, the Department of Health and Human Services (HHS) rescinded actions taken during the Trump administration regarding extramural research funded by the National Institutes of Health (NIH) involving human...more
On May 29, President Trump issued a proclamation, effective on June 1, 2020, to suspend and limit certain nonimmigrant Chinese nationals who seek to enter the United States with an F or J visa. This latest action by the Trump...more
6/9/2020
/ Best Practices ,
China ,
Enforcement Actions ,
Federal Funded Research and Development Centers (FFRDCs) ,
Foreign Nationals ,
Fraud ,
Medical Research ,
Medical School ,
National Institute of Health (NIH) ,
Presidential Proclamations ,
STEM ,
Students ,
Travel Restrictions ,
Trump Administration ,
Universities ,
Visas