In late January, FDA released a draft guidance on CGMP requirements for combination products. The guidance is organized into four main sections, covering: ● background ● general considerations for CGMP compliance ● specific information on 21 CFR 4.4(b), and ● applications for specific types of combination products. The guidance fleshes out the January 2013 final rule 21 CFR 4 on CGMP requirements for combination products.
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