If you weren't paying attention closely late last week, you might easily have missed a small but important announcement made by the US Food and Drug Administration (FDA). By the end of 2014, it says, ...

This is the CTD/IND application series. This time, we will dive deep into eCTD. Japan (PMDA) will make eCTD v4.0 mandatory in April 2026, and the FDA has also begun voluntary acceptance of v4.0. eCTD ...

The US Food and Drug Administration (FDA) has announced the release of "major updates" to Module 1 of the electronic common technical documents (eCTD), used to supplement all eCTD submissions in the ...

To get the executable file, download the zip file from ectd.is and extract all files. To run the program in Windows double click the EU-Module-1.exe in the ...

NEW YORK, Feb. 5 Intrasphere Technologies, a leadingconsulting firm that provides business-focused services and solutions to lifesciences organizations, announced today that the company's ...

// Generates a structured eCTD Module 5 Clinical Study Report (ICH M4E(R2)) // as a multi-section PDF with auto-populated data from VaxEvidence. * Data required to generate an eCTD Module 5 Clinical ...