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
The Office for Human Research Protections (OHRP) released guidance earlier this week in response to the COVID-19 pandemic, encouraging researchers to prioritize public health and safety. The guidance clarifies how the...more
4/10/2020
/ Clinical Trials ,
DATA Act ,
Department of Health and Human Services (HHS) ,
Diversity ,
Drug & Alcohol Abuse ,
Ethics ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Healthcare Fraud ,
Institutional Review Board (IRB) ,
IRB ,
JCORE ,
Medical Research ,
National Institute of Health (NIH) ,
Office for Human Research Protections (OHRP)
Earlier this month the FDA issued guidance listing general factors for study sponsors to take into consideration to assure the safety of clinical trial participants, maintain a good clinical practice, and minimize risks to...more
4/1/2020
/ Clinical Laboratories ,
Clinical Laboratory Testing ,
Clinical Trials ,
Coronavirus/COVID-19 ,
EU ,
Food and Drug Administration (FDA) ,
Guidance Update ,
Infectious Diseases ,
Medical Research ,
Public Health ,
South Africa ,
UK ,
Workplace Safety