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FDA Archive - cunesoft.com

Drug Master File – Count Down

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The FDA deadline on NDA, ANDA, BLA and DMF (paper submissions) is less than 4 weeks away. By 5th of May 2017 the FDA requires that all DMFs are to be submitted in the eCTD format via the Electronic Submissions Gateway (ESG). If your DMF is in paper format with FDA, the same submission does not need to be resubmitted in eCTD format. However, as you move forward it is important to make sure your documents are properly prepared (bookmarked, OCR’d, proper orientation) and you can create your baseline DMF submission as eCTD. The DMF in eCTD format mandate applies to amendments, letters of authorization and annual reports. Read More

IDMP Update

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News and updates from the SPOR Task Force Meeting held on 10 March 2017. As previously communicated, OMS and RMS UAT has been kicked off this week and is still expected to go live for the end of May 2017 and the PMS and SMS go-live is still targeted for mid-2019. The good news is this: new efforts are now in place to build out timelines related to the various approval/project steps and the development and finalization of the EU guidance. The intended benefit of this more formalized project management approach is to ensure that the guidances are developed in a way that meets the requirements in terms of technical components and support for overall processes.

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IDMP State of Affairs

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Current State of IDMP and the phased approach plan

On 25th of September the IRISS EU IDMP Task Force confirmed a phased IDMP implementation approach, while the official legislative date remains 1. July 2016. The European Commission has accepted the phased implementation approach as proposed to HMA in July as follows: Read More