Comments on ICH Q4B draft annexes due next month
This article was originally published in The Gold Sheet
The International Conference on Harmonization recently published three Q4B Step 3 annex documents under the topic "Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions." The draft annex 6 addresses the uniformity of dosage units and the deadline for sending public comment to FDA is April 20. The draft annex 7 deals with dissolution tests and the deadline for comment is April 12. Draft annex 8 covers sterility testing; comments are due April 20
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