Category Archives: Validation

FDA Delays eCTD Requirements for DMF and BPF by 1 year

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Yesterday (Friday April 7, 2017) the FDA announced in an updated guidance that it has delayed until May 5, 2018 the requirement for DMF and BPF submissions to be submitted in eCTD format. Other submission types, NDA, ANDA and BLA, must still meet the 5 May 2017 deadline for submission in eCTD format. For those who have already converted their DMF submissions to eCTD format, you are now 1 year ahead!

References:

Revised FDA Guidance:

4/7/2017 Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (ucm333969.pdf)

RAPS article:

http://www.raps.org/Regulatory-Focus/News/2017/04/07/27301/FDA-Delays-eCTD-Requirements-for-Master-Files/

FDA Posts eCTD Validation Specifications v2.2

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Yes that’s right, 2.2! As you may know, FDA started using Validation Criteria 2.1 on 30 April. In the 2.1 spec all the new/changed items had an “Effective Date” of “Pending”. All 2.2 does is change all the “Pending” to “4/30/2013”. No items were added/deleted/changed. Click here to download the new 2.2 version specifications from the FDA website.

And don’t forget to validate your own eCTDs with v 2.1/2.2 specs now!