miércoles, 12 de abril de 2017

Compliance date extended to May 5, 2018 for submitting Drug Master Files (DMFs) in electronic Common Technical Document (eCTD) format

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)
On April 7, 2017, the FDA announced that it is extending the compliance date for submitting drug master files (DMFs) in electronic common technical document (eCTD) format by one year to May 5, 2018.  The compliance date for submitting NDAs, BLAs, and ANDAs electronically remains unchanged.
The requirement to submit DMFs using the electronic common technical document (eCTD) format is part of FDA’s overall effort to more efficiently review drug applications.  eCTD standardizes how industry submits applications, amendments, supplements, and  reports. Implementing electronic DMFs will improve the efficiency of the DMF review process making it easier for FDA to review applications supported by DMFs, and meet their associated PDUFA and GDUFA performance goals.
The FDA has a number of resources to help DMF holders understand eCTD format and how to submit using eCTD:

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