Category Archive: eCTD

Jan 03 2012

FDA Issues New PDF Specifications

In the chaos of the holidays, you might have missed the release of an important new guidance from FDA.  On 20 December 2011, FDA issued version 3 of “FDA Portable Document Format (PDF) Specifications,” fulfilling a promise made at the recent DIA Electronic Submission conference to release the document by year’s end.  This new version …

Continue reading »

Oct 25 2011

Pre-IND Submissions in eCTD Format

Historically, we made our Pre-IND submissions in paper (e.g., Pre-IND meeting request, briefing package, and meeting minutes) and we began using eCTD format with the initial IND submission.  However, since FDA assigns a Pre-IND number, which ultimately becomes the IND number, and Module 1 includes at least two places that are appropriate for including Pre-IND …

Continue reading »

Oct 04 2011

Health Canada Increases Acceptance of eCTD Electronic-only Filings

Late last week, Health Canada (HC) announced that it is further expanding its acceptance of regulatory submissions in the eCTD electronic-only format. In addition the submission types already accepted in eCTD electronic-only format (including those added to the list earlier this year), HC will now also accept these submission types: Request for Priority Review Status: …

Continue reading »

Sep 07 2011

Transitioning from Paper to eCTD Submissions

A common question that many sponsors ask is, “Can we switch a paper application over to eCTD format?”  The short answer is, “Yes.”  For a more detailed explanation, check out my new guest post over at GlobalSubmit’s blog, The eCTD Summit, where I discuss the complete process for converting an IND, NDA, or BLA from …

Continue reading »

Jul 07 2011

Free Educational Webinar – Reasons to Switch to eCTD

UPDATE: The webinar slides are now available for download here (PDF). The eCTD format continues to grow as the standard for regulatory submissions worldwide, and the FDA has made it very clear that it prefers to receive submissions in eCTD format. However, when many smaller biotech and pharma companies reach the IND or NDA/BLA stages, …

Continue reading »

Jun 30 2011

Clinical Study Reports to STFs

Module 5 - No STF

When working with sponsors who are new to eCTD submissions, one of the most common questions we get is, “What is a Study Tagging File and why do we need one for each clinical study report?”  To explain the importance of Study Tagging Files, we’ve asked Jason Rock, the Chief Technology Officer of GlobalSubmit, to …

Continue reading »

Jun 23 2011

Is FDA Issuing More Refuse-to-File Letters?

  The June 2011 issue of Nature Reviews: Drug Discovery (volume 10, page 403) includes an interesting news brief regarding the apparent increase in Refuse-to-File (RTF) letters being issued by FDA in recent years. In a review of publicly available RTF letters, researchers at Leerink Swann found that 15 RTF letters were issued from 1998 …

Continue reading »

Jun 01 2011

Health Canada Expands Acceptance of eCTD Submissions

Image via cellularhealthcanada.com Last week, Health Canada (HC) issued a Notice to to announce an increase in the types of submissions being accepted by the regulatory authority in the eCTD electronic-only filing format.  Effective immediately, HC now also accepts two new submission types in the eCTD electronic-only filing format: Notifiable Changes (NC) Responses to Clarifaxes …

Continue reading »

Feb 23 2011

Free Webinar – FDA Review Process for eCTD Submissions

Navigating eCTD regulations and guidelines is easier said than done. Same goes for assembling and reviewing applications. That’s why GlobalSubmit and Cato Research are offering a free educational webinar on the FDA Review Process on Tuesday, 01 March at 3:00 PM ET.

Jan 27 2011

Top Reasons to Adopt eCTD Viewing Software

The audience for the eCTD viewer at a drug company ranges from a few users to hundreds or even thousands, depending on the size of the company. Essentially, anyone who writes content, communicates with the FDA, or creates a submission should be using eCTD viewing software. And yet, despite the many advantages and increased global adoption of eCTD submissions, there are still questions and concerns around implementation, in particular among the smaller IND companies.

Older posts «

» Newer posts