FDA: Type III DMF mandatory from 5 May 2020

FDA: Type III DMF mandatory from 5 May 2020

FDA: Type III DMF mandatory from 5 May 2020

FDA updated the guideline for Providing Regulatory Submissions in Electronic Format to reflect that the requirement for Type III drug master files (DMFs) to be filed electronically takes place 60 months after May 5, 2015.

This implies that holders of type III DMFs must submit in eCTD format by 5th May 2020.

Asphalion has extensive experience with preparation of DMFs in electronic format.

For more information please contact [email protected]

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