Business · 28/07/2009

FDA Releases Guidance on Reducing Parvovirus B19 Risk in Plasma-Derived Products

The FDA has released a guidance document dated July 2009, titled 'Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Human Parvovirus B19 Transmission by Plasma-Derived Products,' which provides recommendations for manufacturers of plasma-derived products to perform parvovirus B19 NAT as an in-process test to prevent the use of contaminated plasma units. The guidance finalizes a draft from July 2008 and outlines how to report implementation to the FDA.