On January 6, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) released a joint draft guidance document: Considerations for...more
On January 6, 2025, the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more
After releasing a report requested nearly three years ago, Sen. Elizabeth Warren said the Food and Drug Administration (FDA) and HHS “should clean up the industry to keep patients safe.” The industry to which the Democratic...more
On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs). ...more