Expectations for the Implementation of eCTD v4

Editor’s Note: Jason Rock served as Project Lead for the HL7 RCRIM Expert Working Group that developed the Regulated Product Submissions (RPS) standard. This post is the fourth in a series on the Next Major Version (NMV) of eCTD, eCTD v4.0, which is based on the RPS standard. On December 15, 2015, the International Conference … Continued

FDA’s New Module 1 is a Bridge to eCTD 4

Editor’s note: Jason Rock served as Project Lead for the HL7 RCRIM Expert Working Group that developed the Regulated Product Submissions (RPS) standard. This post is the third in a series on the Next Major Version (NMV) of eCTD, eCTD 4, which is based on the RPS standard. The evolution of the Electronic Common Technical … Continued

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