Business · 30/06/2005
FDA Releases Guidance on Comparability of Biotech/Bio Products Post-Manufacturing Process Changes
The FDA has released a guidance document titled 'Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process' under the International Conference on Harmonisation, outlining principles for assessing the comparability of biotech/bio products before and after manufacturing process changes.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →