Zdrowie i gospodarka · 02/09/2010

FDA Releases Guidance on Harmonization of Pharmacopoeial Texts for Use in ICH Regions

The Food and Drug Administration (FDA) has made available a guidance document outlining the results of the International Conference on Harmonisation's (ICH) Q4B evaluation of the Analytical Sieving General Chapter harmonized text from the United States, European, and Japanese pharmacopoeias, with the aim of promoting a common testing strategy across ICH regions.