Early Preparations for Your Establishment Registration SPL
Jul09

Early Preparations for Your Establishment Registration SPL

When the conversation turns to Structured Product Labeling (SPL) our first thought is often about Prescribing Information. But as the US FDA and other regulatory bodies modernize review processes, electronic submissions are having an impact across more and more communications. Establishment Registration is one of the more critical SPL submissions and must be submitted annually to the FDA in a narrow window.

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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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Five Potential Problems to Avoid when Creating a Structured Product Label (SPL)

In the scheme of a large submission such as an original New Drug Application (NDA), the accompanying Structured Product Label (SPL) is often an afterthought. Small in scope should not be confused for simple – the SPL ranks as the most complex piece of your submission. The SPL standard is based on extensible markup language (XML), and the intricacies of this format are difficult to grasp. If you are unfamiliar with XML the probability...

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Hyperlinking Impact on the Critical Path to eCTD Submission Deadline

This is Part 2 of a larger article on hyperlinking best practices. To read Part 1, Hyperlinking: Making the Most of Navigation in eCTD Submissions, click here.  Regulatory operations is frequently asked about submission turnaround time once the final document is delivered. The strategies around how documents are authored will often have an impact on accurately answering this question. When authors are writing submission documents and...

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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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