June 24, 2021 OPDP eCTD Submission Deadline Approaching – Update #2

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 Each of the required submission types must include certain documents and will not be accepted if the required documents are not included in the submission Form FDA 2253 Each Form FDA 2253 submission must include the following documents: Completed Form FDA 2253: Firms must use the most current version of the fillable form The current form can be found on the OPDP webpage Promotional Materials Current product labeling Labeling must be submitted in section 1.14.6 of the us-regional file For additional guidance, refer to Section IV.A of the OPDP electronic submissions guidance Presubmission of Promotional Materials for Accelerated Approval Products Each Accelerated Approval Presubmission should include the following: Correspondence stating it is a presubmission of promotional materials Clean version of draft promotional materials Annotated copy of proposed promotional materials that clearly identifies the source of support for each claim The most current FDA-Approved prescribing information and, if applicable, FDA-approved patient labeling or medication guide with annotations cross-referenced to the proposed promotional material Sample annotated material can be found here If applicable, annotated references to support product claims not contained in the PI, cross-referenced to the proposed promotional material If applicable, annotated references to support disease or epidemiology information, cross-referenced to the proposed promotional material For additional guidance, refer to Section IV.B of the OPDP electronic submissions guidance Questions related to eCTD submissions to OPDP 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. Refer to the CDER eCTD webpage for more information on creating a New ESG account.   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