Use of Hyperlinks in the Cover Letter for FDA eCTD Submissions

Use of Hyperlinks in the cover letter document – this is another important question as per as Regulatory Operation or Publishing Professional is concerned.

Answer for this question is yes we can use the Hyperlinks in the Cover letter document for eCTD Submissions.

Some of the Pharmaceutical/Biotech companies they are making hyperlinks in the cover letter documents and some of them are not making.

As per as FDA is concerned there is no any specific guidance or standard practice guidance for use of Hyperlinks in eSubmission except Portable Document Format (PDF) Specifications guidance version 2.0.

In this guidance FDA has clearly mentioned “Hypertext links and bookmarks improve navigation through PDF documents. For text, hypertext links throughout the body of the document to supporting annotations, related sections, references, appendices, tables, or figures that are not located on the same page as the narrative text are helpful to improve navigation efficiency.”

FDA eSubmission Team comments regarding use of Hyperlinks in Cover Letter Document
Hyperlinks in the cover letter to other sections of the application are encouraged and can be very helpful to reviewers to Review the submissions.

FDA recommending the sponsor to use Internal Hyperlinks (if there is any need) in the cover letter document however do not include any external hyperlinks (external to the current application) anywhere in the submission.

There are three possible ways for sponsor can make Internal Hyperlinks in the cover letter document.

1) Links within the cover letter document

Example: Page 1 Hyperlinks to Page 2 or 3

2) Create Internal Hyperlinks within the same sequence (For example consider seq 0000)

Example: Cover Document Hyperlinks To Section 1.3.1.1.Change of address Document

3) Create Internal Hyperlinks in the same application but in different sequences (For example consider seq 0001)

Example: Cover Document Hyperlinks To Section 1.3.1.1.Change of address Document

Linking to documents within the same sequence is acceptable and linking to documents in a different sequence in the same application is also acceptable.

However Making External Link is not allowed in the cover letter document. External applies only to linking to a document outside the current application.

For example, a cover letter in ANDA 123456 that links to cover letter in ANDA 456789).