The National Quality Forum is aiming to modernize and standardize serious adverse event reporting via a new patient safety effort. Through the “Focus on HARM” initiative, NQF will update the criteria ...

MANKATO — The number of adverse health events, considered “often preventable,” rose overall at south-central Minnesota health care providers during the latest reporting year. The Minnesota Department ...

Investigators often send reports to sponsors that incorrectly categorize adverse event (AE)s as serious or attribute AEs to investigational drugs. Such errors can contribute to high volumes of ...

Please provide your email address to receive an email when new articles are posted on . The FDA Adverse Event Reporting System will now host daily publications, instead of quarterly. The agency’s goal ...

Two years ago, Congress greatly expanded the authority of the U.S. Food and Drug Administration (FDA) by enacting the Modernization of Cosmetics Regulation Act (MoCRA). This Act requires companies to ...

Per federal regulations, University and affiliate researchers must notify the IRB of unanticipated problems that involve risks to participants or others (henceforth referenced as Unanticipated ...

In a regulatory filing, Soleno Therapeutics (SLNO) disclosed that it is aware that a serious adverse event has been reported in the U.S. Food and Drug Administration’s Adverse Event Reporting System, ...