Zdrowie i gospodarka · 05/08/2008
FDA Releases Draft Guidance on Harmonization of Pharmacopoeial Texts for Non-Sterile Products
The Food and Drug Administration (FDA) has released a draft guidance document outlining the evaluation and recommendation of pharmacopoeial texts for use in the International Conference on Harmonisation regions. The document aims to recognize the interchangeability of local regional pharmacopoeias, reducing redundant testing and promoting a common testing strategy across regulatory regions.
Source: Federal Register — Food and Drug AdministrationOpen original release →