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Posts tagged ‘eCTD’

On February 4, 2016, the U.S. Food and Drug Administration (FDA) hosted a webinar regarding upcoming electronic filing requirements for Drug Master Files (DMFs).  FDA will require DMFs, as well as other pharmaceutical applications, to be filed in electronic common technical document (eCTD) format beginning May 5, 2017. Any paper submissions filed on or after […]

On May 5, 2015, the U.S. Food and Drug Administration (FDA) published a final guidance document requiring certain pharmaceutical product applications to be submitted in Electronic Common Technical Document (eCTD) format.  FDA will require electronic submissions of the following applications: Certain investigational new drug applications (INDs) New drug applications (NDAs) Abbreviated new drug applications (ANDAs) […]

The fastest way to submit Drug Master Files to the U.S. Food and Drug Administration (FDA) is by Electronic Common Technical Documents (“eCTD”) submission. Since eCTD formatted applications are submitted electronically, FDA receives the submission instantaneously. The eCTD format also decreases the time needed to review DMF applications. All of these translate into more ease […]

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