Hyperlinking Best Practices: Common Issue in PDF Rendition
Mar25

Hyperlinking Best Practices: Common Issue in PDF Rendition

“When you use Word templates with styles and make use of the MS Word ‘cross-referencing’ option, tables, figures, sections, etc. within a given page all are automatically [linked] to their target destinations. However, when you have the same table cross referenced on the same page four (4) times, after rendition to PDF, you must manually break those three (3) extra links and convert the text from blue to black. Do you have this issue or is your EDMS customized to take care of this automatically?”

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Hyperlinking: Making the Most of Navigation in eCTD Submissions
Feb05

Hyperlinking: Making the Most of Navigation in eCTD Submissions

When authors generate documents intended for electronic submission they use blue-colored font to indicate where a hyperlink should be added to allow the reviewer to easily access the cross-referenced information. Hyperlinks guide the reviewer closer to the source data or supportive information cited in the body of a document. There are a few industry standards with regards to hyperlinking in submissions.

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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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Converting a Paper IND to eCTD Format
Jan22

Converting a Paper IND to eCTD Format

Conversion of a paper IND to eCTD format can be done at any time the sponsor is ready to implement eCTD. It is important to note that once an eCTD submission has been made to an application all subsequent submissions to that application must also be in eCTD format. Typically, the first submission sent to the application as an eCTD will contain the appropriate form (1571 or 356h) and cover letter indicating that all future submissions...

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New FDA M1 Specifications include DDMAC, Bundled Submissions

As reported last month, the two significant changes to the specifications are is inclusion of DDMAC submission and bundled submissions. The largest change to FDA’s regional DTD is now one sequence can be submitted to multiple applications. This is a great feature if you create a single submission and replicate it to send to multiple applications. The only drawback to this plan is once you submit a bundled submission, the lifecycle for the document submitted cannot diverge in any of the applications.

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