- October 13, 2021
8:45 AM - 4:00 PM ET
Drug Registration and Listing Branch
Division of Labeling, Registration and Unapproved Drugs
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance | CDER
ABOUT THIS CONFERENCE
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
- Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
- Drug Registration and Listing Website
- Structured Product Labeling Resources
- CDER Direct Login and links
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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 course has been:
- 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.
- 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