Search Results for keywords:"public health emergency"

The Food and Drug Administration (FDA) released new guidelines for testing alcohols like ethanol and isopropyl alcohol for methanol contamination, especially during the COVID-19 pandemic. The guidance alerts pharmaceutical manufacturers and pharmacists about the dangers of using methanol-contaminated alcohols in drug products, which can pose significant health risks. Due to the urgent health emergency, these guidelines were issued without prior public comment and are immediately effective, although they can still receive comments for future updates. The guidance aims to ensure the safe use of pharmaceutical alcohol by focusing on proper identity testing and supply chain oversight.

The Food and Drug Administration (FDA) has released draft guidance on how in vitro diagnostic devices (IVDs) should be validated during emergencies involving emerging pathogens, declared under Section 564. This guidance is currently in draft form and not yet ready for implementation. It gives general recommendations for testing devices to ensure they are accurate and reliable during health crises like disease outbreaks. The FDA encourages public comments on the draft by March 10, 2025, either electronically or by mail, before finalizing the guidance.