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KFDA drafts guideline for safety test of biological products
The Korea Food and Drug Administration (KFDA) has come up with a draft guideline for safety test of biological drugs
The draft guideline requires no submission of test results based on long-term storage test and redefines the pilot batch and approval criteria.
In establishing the expiration date of raw materials, the proposed guideline acknowledges the data using more than three pilot ba...
The draft guideline requires no submission of test results based on long-term storage test and redefines the pilot batch and approval criteria.
In establishing the expiration date of raw materials, the proposed guideline acknowledges the data using more than three pilot ba...
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