Updated ICH eCTD Specification Sets Requirements for Collapsed Bookmarks, Unique Headers or Footers
Apr08

Updated ICH eCTD Specification Sets Requirements for Collapsed Bookmarks, Unique Headers or Footers

The International Conference on Harmonization recently published a new Specification for Submission Formats for eCTD document. The document achieved ICH step 4 classification, meaning it’s approved for use by all regions. Collapsing bookmarks when documents are opened, a requirement for unique headers or footers on all pages and a limited set of fonts that are recommended for embedding are among the most notable new rules.

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Placement of DMF Reference Letters
Mar14

Placement of DMF Reference Letters

Rather than submit key information in Module 3 of an application (ANDA, BLA, IND, or NDA), it’s become increasingly common for sponsors to reference a Drug Master File (DMF). Referencing a DMF allows the component manufacturer of the drug or biologic to share proprietary information with the US FDA without having to directly share the information with the sponsor.

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The Case for Tracking Regulatory Submissions
Dec15

The Case for Tracking Regulatory Submissions

The Submission Tracker assigns key dates to deliverables, for example, when a deliverable will be provided for publishing and when certain tasks related to that deliverable must be completed to in order to promote it to submission ready. The tracker is used to determine if submission content is being provided according to schedule and if publishers are completing tasks on time.

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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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