FDA releases new Electronic Submissions Requirements for Biological Products.
Continuing their efforts in the electronic submissions initiative, the Lot Distribution Report [LDR] is next in line to adopt a standardized digital submission format. Beginning in June 2015, the FDA will require all Lot Distribution Reports to be submitted in the Structured Product Labeling [SPL] format.
i4i has already begun development on this new SPL requirement which will be supported in our industry leading SPL solution - A4L. Contact us with any questions. More on the FDA's electronic submissions and reporting requirements for the LDR can be found here.
September 18th, 2014
September 18th, NLM SPL/DailyMed Jamboree Workshop in Bethesda, MD - i4i will be there!
i4i will once again join participants from the FDA, NLM and the pharmaceutical industry, for this annual event. This year the focus is on the "Practical use of DailyMed and RxNorm Drug Data". i4i continues to be involved in the evolution of the FDA SPL initiative as well as developing areas such as IDMP and is committed to providing current XML content and regulatory solutions to their pharmaceutical industry clients.
i4i welcomes creative and innovative global pharma company to the fold
Ready to bring intelligent structured authoring and lifecycle management to their EU, US and Corporate drug product information a creative and innovative global pharmaceutical company embarks on the first phase of implementation and roll out with i4i's global labeling solution.
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.