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 October 18, the Food and Drug Administration (FDA) issued a letter reminding developers of in vitro diagnostics (IVDs) that institutional review board (IRB) approval is required before initiating a clinical investigation...more
10/25/2021
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Investigational Device Exemptions ,
Investigations ,
IRB ,
Life Sciences ,
Medical Devices ,
Research and Development ,
The Common Rule
On April 16, 2021, the Department of Health and Human Services (HHS) rescinded actions taken during the Trump administration regarding extramural research funded by the National Institutes of Health (NIH) involving human...more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 March 17, the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services (HHS) all took steps to improve access to COVID-19 screening. HHS...more
In an unprecedented move touted as necessary to address the COVID-19 testing shortage, the U.S. Department of Health and Human Services (HHS) made a brief statement on August 19 that effectively rescinded the federal Food and...more
9/3/2020
/ CARES Act ,
Clinical Laboratories ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Use Authorization (EUA) ,
Families First Coronavirus Response Act (FFCRA) ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Public Health Emergency ,
Uninsured Patients ,
Virus Testing
The National Institutes of Health (NIH) has warned clinical trial sponsors – including not only drug and device companies, but also universities and hospitals with investigator-initiated trials – to submit significant...more
8/5/2020
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Health Care Providers ,
Hospitals ,
Medical Devices ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Physicians ,
Policy Updates ,
Public Health Service (PHS) ,
Reporting Requirements ,
Universities
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)
On March 19, 2020, the Federal Emergency Management Agency (FEMA) issued a Fact Sheet providing additional guidance on emergency protective measures that may be eligible for funding under the Stafford Act when incurred by a...more
March 3, 2020, the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services published the 2020 edition of the International Compilation of Human Research Standards, available here. The...more