Search Results for keywords:"HCT/Ps"

The Food and Drug Administration (FDA) has released new guidance aimed at reducing the risk of disease transmission caused by sepsis in human cell and tissue products. This guidance is designed to help organizations that make donor eligibility decisions by recommending practices to lower infection risks. The FDA issued this guidance immediately due to urgent health concerns, updating previous recommendations from 2007. The guidance reflects the FDA's current viewpoints but does not impose any legal obligations.

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.

The Food and Drug Administration (FDA) has released three draft guidelines aimed at reducing the transmission risk of hepatitis B (HBV), hepatitis C (HCV), and HIV through human cells and tissues. These guidelines update previous recommendations to help organizations determine donor eligibility through proper screening and testing. Comments on these drafts are encouraged by February 6, 2025, and can be submitted electronically or in writing. The drafts also advise on eliminating certain donor screening questions and focus on assessing each donor's risk based on relevant factors, regardless of gender.