Search Results for keywords:"Mycobacterium tuberculosis"

The Food and Drug Administration (FDA) has released revised final guidances to minimize the risk of spreading disease agents like sepsis and Mycobacterium tuberculosis through human cells, tissues, and related products. The guidances originally advised establishments to implement recommendations within four weeks, but now suggest a longer timeframe until May 4, 2025, to allow for further review and consideration of public comments. These changes follow a presidential directive for regulatory review, prioritizing public health while seeking further input. The FDA emphasizes that these updates are being implemented immediately, even as they remain open to additional public comments.

The Food and Drug Administration (FDA) has released a new guidance to help reduce the risk of transmitting Mycobacterium tuberculosis (Mtb) through human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance provides recommendations for screening donors to check for signs and risk factors of tuberculosis infection. This document was issued urgently due to recent multistate outbreaks linked to Mtb transmissions from donors and aims to enhance screening until official tests are available. Although the guidance is effective immediately, the FDA is open to receiving comments on it.