June 24, 2021 OPDP eCTD Submission Deadline Approaching – Update #4

Starting June 24, 2021, certain submissions to OPDP will be mandatory in eCTD format.   Effective June 24, 2021, the following submission types will only be accepted in eCTD format and may only be submitted through the Electronic Submissions Gateway (ESG): Form FDA 2253 Accelerated Approval Presubmissions eCTD-required submission types will no longer be accepted through the CDER nextGen Portal starting June 24, 2021 Sponsors may continue to submit non-required promotional submissions through the CDER nextGen Portal on and after June 24, 2021 OPDP encourages Sponsors who choose to submit non-required promotional submissions in non-eCTD format to utilize the CDER nextGen Portal Questions regarding promotional submissions to the CDER nextGen Portal can be emailed to OPDPeCTD@fda.hhs.gov New ESG account requests should be submitted no later than one week prior to the June 24 deadline to allow enough time for creation of new accounts. New ESG account requests should be submitted no later than one week prior to the June 24 deadline to allow enough time for creation of new accounts. For information on setting up an ESG account, please visit www.fda.gov/esg. The ESG Helpdesk can be reached at esghelpdesk@fda.hhs.gov.   This notice is being sent via the OPDP listserv and is one in a series of updates that will be sent each week between now and June 24, 2021. Be on the lookout for new announcements each week. Manage Subscriptions  |  Unsubscribe All  |  Help This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA