New FDA Recommendations for PDFs
By Scott Mackey | February 17, 2011
My brain is full of all the new pharmaceutical industry news and updates I’ve gleaned during DIA EDM 2011. Here are a few of the highlights, as I tear down the Adlib booth and rush for the exit like everyone else tonight!
The New RPS Standard
During the FDA update session - which nearly everyone at the show attended – there was an update on the new Regulated Product Submission (RPS) standard which is replacing the eCTD standard. They are finishing off the details and hope to post a ballot to the community in May. If that happens, the target implementation for accepting RPS-based eCTD submissions will be mid 2013. There were comments at the show today about the ballot being delayed until September 2011, which would consequently delay the RPS implementation until later in 2013.
Additional details are being gathered, but the FDA listed a series of new recommendations related to the PDF submissions, including:
- Specific recommendations about using only standard fonts, and to ensure they are embedded. This will mean that FDA reviewers can view/access the content
- The mention of turning image-only documents into searchable PDFs to facilitate content search by reviewers
- The need to optimize PDFs both for ‘fast web view’ and for optimized (read: smaller) file size. Fast web view – or linearization - allows PDF viewers to select a page and view it instantly without having to wait for the whole file to load. This is important for submission PDFs, which can be hundreds of pages each. Smaller file size accelerates the transmission of PDF content but also contributes to reducing the cost of storing submissions for the sponsoring companies and the FDA.
Life sciences companies deal with huge volumes of content; managing the growing tide of electronic content is the responsibility of several groups within each enterprise. Some deal with content in its active state, others need to archive content once it’s finished being leveraged. These are the archivists.
When you deal with petabytes of information – Pfizer mentioned an incredible 4.1 petabytes! – then content format, file size and metadata classification become critical. PDF is the standard adopted across multiple industries including life sciences. For the first time at a DIA event, I heard discussion about the use of the PDF/A ISO standard. (Adlib is a member of the PDF/A Competence Center.) Automating the transformation of content to archive-ready PDF is key because it allows costs to be contained with creating a high quality archive.
The show is now wrapping up, the exhibitors have torn down their booths and everyone is scrambling for the exits. We’ll see them all again next year!
About the Author
As a senior executive, Scott has spent the last 20 years building Adlib into the thriving organization it is today. Scott has held customer-focused leadership roles spanning success, professional services, marketing, and support. He is passionate about business growth, the human impact of technology, and the pursuit of an ideal customer experience measured in the customers’ terms.