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  • hg93 replied to the topic "Combination Product Phase I clinical Studies"4 years, 12 months ago

    Design plans are just a plan. In fact, this is stated in both Clause 7.3.1 of the ISO Standards, and in Section 21 CFR 820.30b of the FDA QSR.Design control for 1st phase include the following 16 tasks: Identification of…   Read more»