FDA move to only accept eSubmissions

FDA LogoWith the progress of technology we are bit by bit transitioning to working paperlessly in a range of different industries. In the pharmaceutical industry, this has been evident since 2003 when the US Food and Drug Administration (FDA) started accepting submissions using electronic common technical document (eCTD) specifications. So far the transition to eSubmissions to the FDA has been optional. However, most pharmaceutical companies have already adopted the use of eSubmissions.

By May 2017, the submission of eCTD will be mandatory for New Drug Applications, Abbreviated New Drug Applications and Biologics Licence Applications. In May 2018, Commercial Investigational New Drug applications are also to become compulsory, with a start in May 2018.

By having manufacturers submitting their applications electronically, the workload of the FDA is eased. Submissions by paper are not only daunting in physical size with page numbers sometimes ranging in the tens of thousands, but the searchability of those papers is also virtually nil – leaving the reviewer to riffle through the pages to find a referenced document.

Here at Debenu we are paying close attention to the changes in the eCTD requirements, constantly working to improve Debenu PDF Aerialist Pharma so that it meets the demands for preparing documents for eSubmissions.

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Debenu Quick PDF Library 11.15 Beta 1 Released

Debenu Quick PDF Library 11.15 Beta 1 has been released and is ready for downloading and testing. This beta is for the Windows version only.  The 11.15 Beta 1 installer can be downloaded from the button below.

Download Debenu Quick PDF Library

There is also a new Android beta with Visual Studio and Android Studio samples included and a new LIB edition 32-bit/64-bit available from Debenu Labs:

Release Notes

New functions

  • SetSignProcessCustomDict function added
  • SetSignProcessFieldImageFromString function added
  • SetSignProcessPFXFromString function added
  • SetSignProcessFieldImageFromStream function added
  • SetSignProcessPFXFromStream function added

Bug fixes

  • Fixed loading of PDFs with padded xref section numbers
  • Fixed rendering issue with color background
  • Fixed EMF to PDF conversion missing cross pattern
  • Fixed printing issue that resulted in black box
  • Embedded font rendering issue
  • Fixed RenderDocumentToFile for full paths without file extension

Upgrading To Version 11

If you are still using version 7, 8, 9 or 10 and would like to upgrade visit this page:

Feedback! Any feedback large or small is appreciated. We’ll shortly be planning the next round of exciting new features for Debenu Quick PDF Library, so we’d really like to know what you want to see added to the SDK. Don’t be shy, email us and have your say.

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ARCS Sydney 2015 Final Day

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It’s the final day at ARCS Scientific Congress Sydney 2015, come by the Debenu booth — it looks exactly like the one above — and say hello to some of the team. We’re here to answer any of your PDF, eCTD, document workflow and eSubmission questions.

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Debenu PDF Aerialist Pharma and ARCS Sydney 2015

2015 ARCS Scientific CongressFor anyone in Pharma/Healthcare that isn’t aware, the Therapeutic Goods Administration (TGA) in Australia is moving forwards with the use of submissions in the Electronic Common Technical Document (eCTD) format, with the aim of accepting eCTD submissions in June 2015. Their initial pilot program of the eSubmission application process has now finished, and the final version of the eCTD specifications for Australia can be found here.

The Debenu team will be attending the ARCS Scientific Conference in Sydney, 5-7 May.

If you are going (which you should), make sure to listen to the talk on Wednesday 6 May at 11.15; B7 – “eCTD in Australia and Experience in the Pilot Programme”. There will be an overview from the TGA’s pilot programme, an update of the eCTD specifications for Australia and a look into the technical side of eCTD’s.

The transition to eSubmissions might seem daunting at first. However, there are a range of established publishing tools (Lorenz DocuBridge, eCTD Office, etc) to help you compile your submissions into the right format. On the PDF preparation side of things there is Debenu PDF Aerialist Pharma which dramatically increases the productivity of the regulatory affairs person working on the submission, but also for the reviewer receiving it.

Debenu PDF Aerialist Pharma, an Adobe Acrobat plug-in, allows for the automated addition of TOCs, bookmarks and hyperlinks to the documents, as well as audit reports, ensuring that the standards required are met every time.

Debenu will be at the conference all three days, answering any questions you have about your PDF’s and how we can streamline your workflow to make your documents match the new specifications. Come by the Debenu booth and say hi to the team. We hope to see you there!

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Debenu Quick PDF Library 11.14 Released

The final version of Debenu Quick PDF Library 11.14 for Windows, Mac and iOS has been released and is ready for download from our product updates page.

This new version includes Delphi XE8 support for Delphi programmers, lots of improvements of users of the iOS version to stability and performance, and a wide range of improvements for users of the PDF SDK on Windows, Mac and iOS such as improved rendering, font handling, annotation and OCG enhancements.

The Mac and iOS versions use a new internal font processing library which should see major improvements to font handling by the library on these platforms (Windows version makes use of the Windows API which is not available on other platforms). Visit the product updates page to download this new version and see a full list of the changes.

Download 11.14 from our Product Updates page

Version 11.14 Highlights

  • Delphi XE8 Support (Windows only)
  • Added new GetImageListItemFormatDesc function
  • Flate compressed images with masks now extracted as PNG
  • Added support for File HTML tag
  • Fixed font regression problem from 11.13. Characters spaced too far apart in some PDFs
  • Added support to get OverlayText property string from a Redact annotation
  • Fixed AddFreeTextAnnotation clipping issue with large font sizes
  • LoadFromCanvasDC method now accepts font StrikeOut parameter
  • Fixed OCGs print issue according to printState flag
  • Over 18 bug fixes, 4 enhancements and 3 new functions

Upgrading

Debenu Quick PDF Library 11 is a major new version of the product which means that the upgrade process is different from the minor version upgrade process, namely, upgrades are not free unless you meet certain requirements.

Free upgrades

Customers who purchased version 10 of Debenu Quick PDF Library on or after the 10th of July, 2014 (within 60 days of version 11’s release) or who own an active Premium Upgrade Protection subscription are eligible for free upgrades from version 10 to version 11.

Contact our sales team if you fall into this category and we’ll help you out.

Purchase an upgrade

An upgrade from version 10 or earlier versions to version 11 can be purchased at a discount (starting price is $269.00) through our online store. Users can upgrade their Single Developer, Multiple Developer or Source Code licenses to version 11. It’s also possible to purchase Premium Upgrade Protection with your upgrade purchase.

For example, if you own a Single Developer License + Standard Upgrade Protection for version 10 of Debenu Quick PDF Library then you will need to purchase the Single Developer Upgrade License + Standard Upgrade Protection (10.x to 11.x) product in order to upgrade to version 11 — though you can choose to buy the Premium Upgrade Protection version of that product if you prefer.

Feedback

As always we’d love to hear your thoughts on the new version of Debenu Quick PDF Library. If you have any questions, comments or general feedback, please let us know.

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Debenu PDF Viewer SDK 11.14 Release

The final version of Debenu PDF Viewer SDK 11.14.1.0 has been released and is ready for download from our product updates page.

This new version is a minor release with just bug fixes and an updated to the core PDF SDK we recommend that all customers upgrade to it to take advantage of the improvements. Visit the product updates page to download this new version and see a full list of the changes.

Download 11.14 from our Product Updates page

Version 11.14 Highlights

  • Added new pageMouseDblClick event
  • Fixed CloseFile function to fully close all elements
  • Fixed issue with changing NavigationPaneEnabled property
  • Updated to use Debenu Quick PDF Library 11.14

Try the new version

A full list of the changes in Debenu PDF Viewer SDK 11 can be found on our product updates page. You can also download a 30 day limitation-free trial version of the library.

Upgrading

Debenu PDF Viewer SDK 11 is a major new version of the product which means that the upgrade process is different from the minor version upgrade process, namely, upgrades are not free unless you meet certain requirements.

Free upgrades

Customers who purchased version 11 of Debenu PDF Viewer SDK on or after the 10th of July, 2014 (within 60 days of version 11’s release) or who own an active Premium Upgrade Protection subscription are eligible for free upgrades from version 10 to version 11.

Contact our sales team if you fall into this category and we’ll help you out.

Purchase an upgrade

An upgrade from version 10 to version 11 can be purchased at a discount (starting price is $210.00) through our online store. Users can upgrade their Single Developer or Multiple Developer licenses to version 11. It’s also possible to purchase Premium Upgrade Protection with your upgrade purchase.

For example, if you own a Single Developer License + Standard Upgrade Protection for version 10 of Debenu PDF Viewer SDK then you will need to purchase the Single Developer Upgrade License + Standard Upgrade Protection (11.x to 12.x) product in order to upgrade to version 11 -— though you can choose to buy the Premium Upgrade Protection version of that product if you prefer.

Feedback

As always we’d love to hear your thoughts on the new version of Debenu PDF Viewer SDK. If you have any questions, comments or general feedback, please let us know.

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Debenu Quick PDF Library Lite 11.14 Released, Includes iOS support and New Features

Version 11.14 of Debenu Quick PDF Library Lite, our free PDF SDK, has been released and it is a fantastic new release. Not only does it now include an iOS version and a 64-bit Mac version, but we’ve also added new great features for page extraction, image analysis and font presence analysis.

Version 11.14 Highlights

Download

The latest versions of Debenu Quick PDF Library Lite for Windows, Mac and iOS can be downloaded from the PDF Library Lite download page.

Feedback

As always we’d love to hear your thoughts on the new version of Debenu Quick PDF Library Lite. If you have any questions, comments or general feedback, please leave a comment!

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New Beta Release for Android and iOS Versions of Debenu Quick PDF Library

We’re gearing up for the version 11.14 release of Debenu Quick PDF Library for Windows, Mac, iOS and Android at the end of next week. In the mean time we’ve released a new beta of the iOS and Android versions as there has been numerous optimizations to improve performance for these platforms, especially around font and string management.

The beta versions can be downloaded from the Debenu Labs website:

As always, we’ve love to hear your feedback.

 

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Android PDF Library SDK Beta Released

Debenu Quick PDF Library for AndroidWe’re excited to announce the first public beta of our new Debenu Quick PDF Library for Android. This Android PDF Library SDK release follows hot on the heels of the iOS PDF Library release we did just a short-time ago in January and will be followed by a Linux release in a few months time.

It’s an exciting time for Debenu customers and the Debenu team as we take our already popular Windows and Mac PDF Library and make it truly cross-platform and device independent.

The Android PDF Library SDK beta can be downloaded from the Debenu Labs website.

We really look forward to your feedback on this new release and want to hear from you if you’d like to see any additional support for our new Android library added such as better support for Android Studio, Eclipse or Visual Studio.

Stay tuned for the next Android release and Linux support coming soon!

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Debenu Quick PDF Library 11.14 Beta 2 Released

Debenu Quick PDF Library 11.14 Beta 2 has been released and is ready for downloading and testing. This beta is for the Windows version only.  The 11.14 Beta 2 installer can be downloaded from the button below.

Download Debenu Quick PDF Library

Release Notes

New functions

  • SetAnnotOptional function added
  • AddFreeTextAnnotationEx function added

Bug fixes

  • Fixed rendering of B/W TIFF image with DeviceN colorspace
  • Fixed font regression problem from 11.13. Characters spaced too far apart in some PDFs
  • Fixed Type3 font rendering issue with CharSpacing and WordSpacing
  • Fixed NormalizePage to correctly rotate rotated annotations
  • Added support to get OverlayText property string from a Redact annotation
  • Fixed bug in LinearizeFile function
  • Fixed text extraction bounding boxes for some rare PDF files
  • Update to the EncodePermissions function reference
  • Fixed bug in separation color space values
  • Fixed invalid clipping rectangle bug in GDI+
  • Fixed barcode rendering bug in GDI+
  • Bug fix for AddFreetextAnnotation to resolve Options parameter issues
  • Updated function descriptions for AddFreeTextAnnotationEx and AddFreeTextAnnotation

Upgrading To Version 11

If you are still using version 7, 8, 9 or 10 and would like to upgrade visit this page:

Feedback! Any feedback large or small is appreciated. We’ll shortly be planning the next round of exciting new features for Debenu Quick PDF Library, so we’d really like to know what you want to see added to the SDK. Don’t be shy, email us and have your say.

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