RAPS

FDA Unveils New Changes to eCTD Submission Formats

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, ...
RAPS

'Major Updates' to eCTD Module 1 Released by FDA

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 ...
Yahoo Finance

1 Day Mastering Generic CTD Submissions in the MENA Training Course: Specific Documentation and Study Requirements Essential for Successful Submissions (ONLINE EVENT: May 19, 2026)

Dublin, April 10, 2026 (GLOBE NEWSWIRE)-- The "Mastering CTD Submissions in the MENA Region (May 19, 2026)" training has been added to ResearchAndMarkets.com's offering. Unlock a deeper understanding ...
JD Supra

EMA's revised guideline on manufacture of the finished dosage form

The European Medicines Agency (EMA) has adopted a new guideline on manufacture of the finished dosage form of medicinal products for human use (“the new Guideline”). The new guideline replaces the ...