June 24, 2021 OPDP eCTD Submission Deadline Approaching – Update #1

Starting June 24, 2021, certain submissions to OPDP will be mandatory in eCTD format.   The following submission types will be mandatory in eCTD format starting June 24, 2021 and may only be submitted through the Electronic Submissions Gateway (ESG): Form FDA 2253 Accelerated Approval Pre-submissions All other submission types to OPDP may be submitted in eCTD format but there is no requirement to do so Non-mandatory submission types will be accepted in the following formats: eCTD format submitted through the ESG non-eCTD electronic format submitted through the CDER nextGen Portal paper format submitted via delivery services to FDA Refer to the OPDP electronic submissions guidance for details on eCTD submissions to OPDP Additional resources are available at the OPDP eCTD webpage 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 sufficient 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 the first 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