Electronic Drug Registration and Listing
Using CDER Direct
October 13, 2021
This event is FREE to attend
This conference is part of the SBIA Regulatory Education for Industry (REdI) series and is intended to provide basic instruction in the registration and listing policy and process for those who are new to this regulatory program as well as offer regulatory professionals more in-depth information on issues and current events affecting Drug Registration and Listing.
- Registration and Listing 101: FDA will demonstrate using CDER Direct how to create and submit:
- Establishment Registration and De-Registration
- Labeler Code Request and Update
- OTC and Rx Product Listing and Update
- NDC Reservation
- 503B Compounder Registration and Product Report
- FDA will discuss:
- the structure, use, and future of the National Drug Code (NDC) number
- common errors and issues encountered with submissions
- FDA will provide an overview of:
- the compliance program and process and steps a registrant should take if they receive a deficiency letter.
- the Over-The-Counter Monograph User Fee Program (OMUFA) and how registration is used to calculate fees.
Who Should Attend?
- Regulatory affairs professionals working on Registration and Listing or who submit structured product labeling (SPL) to FDA
- Members of pharmaceutical industry who submit Registration and Listing
- Human drug compounding outsourcing facilities
- U.S. Agents for foreign registrants
- Importers and import agents
- Consultants and law firms representing pharmaceutical companies
The agenda may be updated as changes are made. The current version is Version 3, updated on September 1, 2021.
The speaker biographies document is currently under development. It will be linked here as soon as it is available.
The virtual conference will be hosted via Adobe Connect and is limited to 2,000 simultaneous attendees. If a room is full when you attempt to enter, please try the other room.
The links below to the Adobe Connect rooms will be activated about 15 minutes before each day begins.
Room One will open 15 minutes before the event begins.
Please try Room One first.
Room Two will only be activated if Room One exceeds 1,000 participants.
Please do not join both rooms at the same time.
The audio for the event will be provided through your computer speakers via Adobe Connect (there will NOT be a teleconference number to dial into). We recommend that you test your PC or mobile device prior to the event and you join the event a few minutes early to address any issues.
To test your PC, please visit:
(The link above will become active approximately 24 hours before the event begins)
Final Evaluation & Certificate of Attendance
(The text above will be linked to the evaluation at the end of the event)
NOTE: The link to download the certificate will be shown upon completion of the evaluation.
Links to recordings will be added here as they become available.
- pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
- pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.
- pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.
This workshop has been:
If you have questions regarding the content of the event or other CDER-specific information, please: