As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...

The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...

The suit, filed on Jan. 8, argues that the new protocol — it relies on a single drug, pentobarbital, to induce respiratory and cardiac arrest, instead of the three-drug cocktail Tennessee used for ...

A recent study found that up to 40% of trials might be untrustworthy due to flaws in design, improper data collection, and ...

Researchers at The Hospital for Sick Children (SickKids), working with international collaborators and youth and family caregivers, have developed a child- and youth-centred global standard for ...