Patient safety organizations
This article was originally published in The Gray Sheet
HHS on Nov. 21 finalized a 1regulation establishing patient safety organizations - third-party groups certified by the government to accept patient safety event information from health care practitioners on a confidential basis. Required by the Patient Safety and Quality Improvement Act of 2005, PSOs are intended to give practitioners a way to report events without fear that the information will be used against them in lawsuits or professional sanctions. They do not negate FDA adverse event reporting requirements for devices and drugs (2"The Gray Sheet" Feb. 18, 2008, p. 7)
You may also be interested in...
A proposed federal rule could increase the number of adverse event reports available for public analysis
Purell Battling Class Actions Over Disease Claims While World Scrambles To Increase Hand Sanitizer Supplies
Leading chemical firms, beauty and consumer health companies, even distilleries and medical marijuana cultivators are adapting operations to meet global demand for hand sanitizers amid the COVID-19 pandemic. Meanwhile, plaintiff’s attorneys are busy with multiple class actions against Purell manufacturer GOJO Industries for alleged false advertising following a January warning letter to the firm from the US FDA.
FDA's Emergency Use Authorization for Malaria Drugs Could Hinder Trials of Other COVID-19 Treatments
Questions linger about the role the White House played in pushing the EUA, which comes with large product donations from Bayer and Sandoz that are expected to alleviate supply chain pressures for the drugs.