Topic: Responses to Authority Questions
The FDA, EMA, and PMDA Questions: How to Respond During Review of CTD Submission Dossiers
While the ICH’s Common Technical Document (CTD) is an internationally agreed format for preparing application dossiers needed for obtaining approval to market a drug, the ensuing review process is specific to the country or region in question. Irrespective of the differences in process between countries and regions, questions will almost always be issued during the review process, with a request for written responses.
Author: Douglas Fiebig
Journal: International Clinical Trials
Date: November 2021
Finding the Answers
Responding to authority questions - how medical writers can streamline the relay race.
Author: Julia Forjanic Klapproth
Journal: European Pharmaceutical Contractor, EPC
Date: March 2012