Detailed Requirements concerning the DOE in the Regulatory Submission Dossier: EMA’s and FDA’s Recommendations
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL:
The EMA has published together with the FDA a new question & answer (Q&A) paper at the end of 2014. This document answers questions on detailed requirements in connection with the documents concerning regulatory submissions. Among others it contains the answer to the question “What level of detail should be considered for design of…