The Food and Drug Administration ("FDA") expands informed consent exceptions with a final rule permitting institutional review board ("IRB") waiver or alteration of elements for certain FDA-regulated minimal-risk clinical...more
Note From the Editors -
This edition of Vital Signs is filled with digital health developments from around the world. In Industry Insights, you'll see and hear from Alexis Gilroy and Claire Castles, each in a short video...more
5/15/2023
/ Clinical Trials ,
Data Collection ,
DEA ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
OIG ,
Popular ,
Substance Abuse ,
Telehealth
The Situation: Pregnant women have historically been excluded from clinical trials due to concerns about the potential for adverse effects on pregnant women and their fetuses.
The Development: The U.S. Food and Drug...more
In March 1997, the Food and Drug Administration ("FDA") published a final rule, codified in 21 CFR Part 11 ("Part 11"), establishing the privacy, security, and reliability criteria for electronic records and electronic...more