ICH stability guidelines would cause "hardship" to OTC, ANDA products -- Perrigo.
This article was originally published in The Tan Sheet
Executive Summary
ICH STABILITY GUIDELINES WOULD CAUSE "SIGNIFICANT HARDSHIP" to manufacturers of OTC monograph and generic drugs, Perrigo maintained in Jan. 10 comments to FDA. The comments addressed the International Conference on Harmonisation final guideline entitled "Stability Testing of New Drug Substances and Products," published by FDA in the Sept. 22, 1994 Federal Register. The guideline was developed under the auspices of the ICH on Technical Requirements for Registration of Pharmaceuticals for Human Use.
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