June 24, 2021 OPDP eCTD Submission Deadline Approaching – Update #5

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 Firms are encouraged to submit promotional materials that promote more than one product as a grouped submission Section VI.J of the OPDP eSub Guidance Submitters may refer to Example #17 in the eCTD Example Submissions document for an example of a properly-structured 2253 grouped submission Grouped 2253 Submissions should include the following items: All items listed in Section IV.A of the OPDP eSub Guidance Completed Form 2253 The Application Number listed on the Form should match the Lead Application in the us-regional file Supplemental Application document which lists the additional member Applications in the group The Supplemental Application document should be placed in the eCTD table of contents under the same section as the completed form Each Application Number listed in the Application Set section of the us-regional file must be accompanied by a unique sequence number that has not been previously submitted If any member Application is submitted with a Sequence Number that has been previously submitted to it's respective Application, the entire submission will be rejected A PDF copy or links to the current PI for each member Application under Heading 1.14.6 Additional considerations for Grouped Submissions Submitters are encouraged to utilize the OPDP eCTD test submission process prior to submitting a grouped submission OPDP Project Managers can review the eCTD structure of the grouped test submission and provide feedback to submitters to ensure submissions are properly structured Contact OPDP at OPDPeCTD@fda.hhs.gov for instructions on submitting a test grouped submission 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