The U.S. Food and Drug Administration (FDA) issued a long-anticipated draft guidance on June 26, 2024, entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical...more
The United States Food and Drug Administration (FDA) issued draft guidance on April 13, 2022, entitled, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical...more
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
The Government Accountability Office (GAO) has agreed to investigate the operations of for-profit Institutional Review Boards (IRBs) following a request made by Senators Elizabeth Warren (D-MA), Sherrod Drown (D-OH), and...more
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
As healthcare providers and universities respond to the spread of COVID-19, legal counsel at these institutions should be prepared to assist their institution’s research enterprise in anticipating and reacting to any changes...more
3/12/2020
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Educational Institutions ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Hospitals ,
Infectious Diseases ,
Institutional Review Board (IRB) ,
Investigational New Drug Application (IND) ,
Medical Devices ,
Medical Research ,
National Institute of Health (NIH) ,
Policies and Procedures ,
Scientific Research ,
Universities