The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times.

The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times.

The guidance, effective 22 June 2012, will supersede an earlier 2003 draft guidance entitled, "Preparation of New Drug Submission in the CTD Format. Read more: Guidance Document: Preparation of Drug ...

The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times.

The US Food and Drug Administration finalized a Guidance for Industry this week that aims to clarify the submission of new drug applications (NDAs) and biologics license applicants (BLAs) using the ...

The European Medicines Agency issued a reminder about the Jan. 1, 2010 deadline for e-CTD submissions. The European Medicines Agency (EMEA) has issued a reminder that the electronic Common Technical ...

DUBLIN, Sept. 17, 2018 /PRNewswire/ --The 'eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada' conference has been added to Research ...