Preparing for the eCTD
This paper will provide a framework for developing eCTD capabilities using a methodology that looks at the submission development process as an organizational rather than a departmental initiative.
RTF Issues An understanding of all regulations is important during the drug development process. The implications of an RTF can be overwhelming and should be avoided. This paper explains the regulations that govern the FDA’s decision and includes examples that would apply for why the FDA may refuse to file a submission.
