12:00 PM - 1:30 PM Eastern
The Common Technical Document (CTD) format is now the required format for all marketing applications in the U.S., EU, Japan, Canada, and Australia. Clinical Trial Applications (CTAs), the required format of INDs in most countries, are required to be in the CTD format. Currently, the U.S. does not require INDs to be in the CTD format, but rather the traditional format (per regulations in 21 CRF 312.23). However, since all marketing applications are required in the CTD format, it is more efficient to start the IND in the CTD format. If you use the traditional format, the IND and all amendment information must be converted to the CTD format prior to marketing application submission. This conversion time can impact the timeline for marketing application submission, so why not plan ahead for a successful marketing application and start the IND in the CTD format?