Zdrowie i gospodarka · 05/08/2008

FDA Releases Draft Guidance on Harmonizing Microbiological Testing for Non-Sterile Products

The Food and Drug Administration (FDA) has made available a draft guidance document outlining the results of the International Conference on Harmonisation's (ICH) Q4B evaluation of microbiological testing methods for non-sterile products, aiming to standardize testing across the US, European, and Japanese regulatory regions.