06-13-17

On February 24th, the EMA published the latest version of the EU eSubmission roadmap. Besides the adaption of eCTD 4.0/ RPS timelines, it includes...

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02-24-17

From May 5, 2017, all new Drug Master Files (DMFs) submitted to the US FDA, as well as any additional submissions relating to existing DMFs, must be...

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