News & Events
May 1 - June 1, 2014
GDUFA Fiscal Year 2015 Self-Identification Period
The Generic Drug User Fee Amendments of 2012 (GDUFA) requires generic drug facilities, and certain sites and organizations identified in a generic drug submission to submit, update, or reconfirm identification information to the FDA annually. For fiscal year 2015 this period will begin on May 1, 2014, and close June 1, 2014.
If you have SPL submission needs and no time to create and update them, take advantage of i4i's SPL conversion and submission team! Assisting customers at moments of high volume/overflow or where there are internal resource limitations keeps our conversion team very busy. Contact us with any questions.
April 25th, 2014
A4L 5.3 is Available for Download
In January the FDA published an update to the Structured Product Labelling (SPL) Implementation Guide with Validation Procedures, this update with subsequent changes and clarification involves new validation rules and procedures for SPL compliance. And depending on your product type, one of the new data elements comes with a deadline of May 1st or September 1st for adherence.
i4i was quick to react and has released the latest version of our flagship pharmaceutical solution, A4L. In addition to meeting SPL guidance requirements, this latest version introduces new capabilities including support for Medical Device SPLs and it enhances the overall existing product.
March 25th - 27th
i4i to Exhibit at the DIA's 26th Annual EuroMeeting in Vienna, Austria
Join us in the City of Music, Austria Center Vienna [ACV] at BOOTH 227 and ask us about the latest innovations in structured content being rolled out to our global customers in the Life Sciences industry.
i4i ramping up to release A4L Pro 5.3 in April
Moving out the release by only a few weeks, i4i was quick to react to the latest updates of the FDA's SPL Validation Rules. A4L Pro 5.3 will be made available in early April. The new release will include support for Medical Devices, updates made to the Structured Product Labeling[SPL] Implementation Guide and Validation Procedures covered in the January vendor training session and for the latest validation requirements announced in mid-February by the FDA. [See the latest e-newsletter or contact us for more details]
i4i participates in FDA's SPL Software Vendor Training Session. This online workshop covered recent changes and updates to the Structured Product Labeling [SPL] Implementation Guide and Validation Procedures. These updates will be incorporated into the upcoming release of A4L 5.3.
i4i delivers structured authoring of regulated documents for leading global financial services firm - on time and on budget!
Best Wishes from i4i! It has been a pleasure helping our valued clients reach their goals over the past year, and we look forward to contributing to further successes in 2014.