Update on non-eCTD Submissions to Office of Prescription Drug Promotion (OPDP)

Update on non-eCTD Submissions to Office of Prescription Drug Promotion (OPDP)

Recognizing that some submissions will be exempt from the eCTD requirement (i.e. Advisory Submissions, Amendments, Response to Information Requests, etc), CDER is providing an alternate electronic submission pathway to sponsors or applicants. OPDP encourages submissions to be made electronically via CDER NextGen Portal for submissions covered under such exemptions rather than paper or physical media.

For information on how to organize a submission covered under such exemptions, please refer to the Providing Regulatory Submissions in Alternate Electronic Format; Draft Guidance for Industry. Please note the draft guidance says to submit via ESG, however, CDER has since opened the CDER NextGen Portal to accept these submissions as well.

For additional information on the promotional submissions which will be exempt from eCTD submission requirements and the contents of those submissions, please refer to the Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs; Final Guidance for Industry.

Any questions related to the submission promotional materials to CDER may be directed to OPDPeCTD@fda.hhs.gov.