FDA PDF Specifications

As many of you know, the FDA issues eCTD Guidance and Specifications to clarify implementation of regulations. In the currently posted specification concerning PDFs dated June 4, 2008, the official PDF version is 1.4, which is supported in Adobe Acrobat 5 and later. As new versions of the PDF specifications are released, they are evaluated for future acceptance. Therefore, the answer to the question “Which version of PDF can I submit?” changes as the PDF standards evolve.

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Next RPS Ballot Delayed Until September 2011

The May 2011 ballot date was missed and is now delayed until September 2011. Why was the date missed? In my opinion, we are still working on refining all of the requirements. We have two requirements left to be finalized; namely, being able to reuse studies and all of the components in two applications and support for the new European variation legislation.

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Harmonizing eCTD Submission Content
Mar17

Harmonizing eCTD Submission Content

As adoption of the Common Technical Document and the eCTD has progressed through the regions, variations in the content and structure of the dossier/application requirements have emerged, making submissions regionally different. This slows the preparation of submission content and delivery, and lobbies against submission efficiency aiding a rapid health product development timeline. Harmonized submission content and structure are lofty goals that often never realistically and unilaterally enter the streamlined equation for product development.

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RPS Working Group Reviews ICH Requirements

The RPS (Regulated Product Submissions) Working Group met last week in Atlanta. The main discussion points were around ICH requirements, multi product submission, facility submissions, linking to other applications, multi regulator submission and how should the project be managed going forward. All current ICH requirements were reviewed. Most of the requirements are already met. Some more requirements need to be addressed. I expect...

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FDA Statistics on NDAs, INDs and ANDAs

This year’s DIA annual meeting was more of a checkpoint rather than revealing startling new information – at least in the eSubmissions area. However, a lot of interesting information was exchanged. Today, I’ll focus on the FDA’s presentations. I’ll follow up later with information from other authorities and industry. Gary Gensinger provided his usual update on eSubmissions at the FDA: In the CDER town hall meeting, Gary noted that FDA...

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