June 24, 2021 OPDP eCTD Submission Deadline Approaching – Update #6

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 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   Frequently Asked Questions Q: What is the four-digit box on the new 2253 Form? A: The four-digit field added to Box 2 on the current version of the Form FDA 2253 is reserved for the Supplement Number of the Submission Tracking Number (STN). This field is optional and is intended for CBER/APLB submitters to provide the pre-assigned Supplement Number associated with the STN, if known. The field should be left blank when the Form FDA 2253 is submitted to CDER/OPDP. Q: Are Sponsor's required to submit any documents prior to submitting their first OPDP eCTD Submission? A: No – A Sponsor will need to create a new ESG Account if they do not already have one but there is no requirement to submit any documents to the Agency before submitting in eCTD format to OPDP. With that said, Sponsors are encouraged to utilize the OPDP eCTD test submission process prior to submitting in eCTD format but there is no requirement to pre-submit test files. Q: Can OPDPeCTD@fda.hhs.gov provide guidance on CBER/APLB submissions? A: No – the OPDP eCTD mailbox can only provide guidance on eCTD submissions to CDER/OPDP. Submitters to CBER/APLB should contact esubprep@cber.fda.gov Q: Which lifecycle operator should be used for revised or updated materials? A: When submitting a revised or updated promotional material to CDER/OPDP, Submitters should use the "Replace" lifecycle operator Q: Are annotations required to include a hyperlink to the referenced PI or reference document? A: No – Annotations should clearly direct the reviewer to the source of support for any promotional claims but the annotations do not need to include a working hyperlink. OPDP has posted a sample annotated promotional material to help illustrate the recommended structure of annotations.   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