Documents Applicable to Multiple Content Locations in CTD Structure

In some cases, a document in an eCTD application may be applicable in more than one content location in the CTD structure. For example, a single nonclinical pharmacokinetic (PK) study may have evaluated both absorption and distribution of the drug. In the CTD structure, the study report could belong in either Module 4 Section 4.2.2.2 Absorption, or Module 4 Section 4.2.2.3 Distribution. The best practice recommendation is for the...

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Analysis of New, Draft TGA (Australia) M1 CTD Guidance (Part 2)

My last analysis of the new TGA (Australia) Draft Module 1 Administrative Information and Prescribing Information left off at section 1.5.5 before analysis paralysis set in… today I wrap up with an examination of the rest of the document. In Section 1.6.1 Relevant external sources, as in most sections, example forms have been replaced with instructions to download forms from the TGA website. In this case, each referenced DMF,...

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Analysis of New, Draft TGA (Australia) M1 CTD Guidance

I sat down to take a look at the new TGA (Australia) Draft Module 1 Administrative Information and Prescribing Information. This is a whopper of a document (96 pages), carefully written to provide a wealth of additional information to sponsors. The document contains a number of major and minor changes, and has been re-formatted to make extensive use of bullet lists for greater clarity. The new guidance addresses subsequent data...

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