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  1. News & Events for Human Drugs

Workshop | Virtual

Event Title
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct
October 13, 2021

Scheduled

Date:
October 13, 2021
Time:
8:45 AM - 4:00 PM ET

 

Topics & Presentations

Speakers

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 1 with Keynote Address

Welcome Remarks from the Director of the Office of Compliance

Keynote - Slides

FDA Website: Resources Available to You - Slides

Drug Establishment Registration 101 – The Basics

  • How to Submit an Establishment Registration - Slides
  • Establishment De-Registration - Slides
  • Labeler Code Request - Slides


Don Ashley
Director, Office of Compliance (OC)
CDER

Paul Loebach
Branch Chief
Drug Registration and Listing Branch (DRLB)
Division of Labeling, Registration and Unapproved Drugs (DLRUD)
Office of Unapproved Drugs and Labeling Compliance (OUDLC) | OC | CDER

Don Duggan
Team Lead, Helpdesk Operations Team (HOT)
DRLB | DLRUD | OUDLC | CDER

Regie Samuel
Technical Information Specialist
HOT | DRLB | DLRUD | OUDLC | CDER

Vikas Arora
Pharmacist
Office of Program and Regulatory Operations (OPRO)
OC | CDER

Puii Huber
Technical Information Specialist
HOT | DRLB | DLRUD | OUDLC | CDER
 

 

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 2

Drug Listing 101 – The Basics - Slides

  • NDC Reservation - Slides
  • How to Delisting/Updating a Product - Slides
  • Annual Certification of Drug Product Listings - Slides

The National Drug Code (NDC): Rules for Assigning and Changing - Slides

503B Human Drug Compounding Outsourcing Facility Registration and Product Reporting 101 – The Basics - Slides

Q&A Panel

Soo Jin Park
LCDR, USPHS
Regulatory Officer
Data Quality and Compliance Team (DQCT)
DRLB | DLRUD | OUDLC | CDER

David Mazyck
Consumer Safety Officer

Troy Cu
Technical Information Specialist

Regie Samuel
Technical Information Specialist
DRLB | DLRUD | OUDLC | CDER
 

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 3

OMUFA Fees for Registered OTC Drug Manufacturers - Slides

Tips, Techniques, and Common Mistakes with Submissions

  • How to Create a Kit Listing - Slides
  • Overrides Request - Slides
  • Common Errors with Repackages or Relabeled Drug Listings - Slides
  • Brief Discussion of Listing for Combination Products - Slides
  • Top 5 Most Common Errors Across All Drug Listings - Slides

Compliance Program - Slides

 

Matt Brancazio
CAPT, USPHS
Branch Chief, Policy and Operations Branch
Division of User Fee Management (DUFM) Office of Management (OM) | CDER

Tasneem Hussain
Pharmacist

Troy Cu
Technical Information Specialist

Paul Loebach
Branch Chief
DRLB | DLRUD | OUDLC | CDER

Leyla Rahjou-Esfandiary
Team Lead
DQCT | DRLB | DLRUD | OUDLC | CDER

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 4 and Closing Remarks

Registration and Listing Deficiency Letters - Slides

Current Compliance Projects:
U.S. Agents - Verification Initiatives & Listing Inactivation Project

  • U.S. Agent Verification Initiative - Slides
  • Drug Listing Inactivations An Overview - Slides

Submission Troubleshooting Exercise

Q&A Panel

Closing Remarks

 

Tasneem Hussain
Pharmacist
DQCT | DRLB | DLRUD | OUDLC | CDER

Leyla Rahjou-Esfandiary
Team Lead
DQCT | DRLB | DLRUD | OUDLC | CDER

Paul Loebach
Branch Chief
DRLB | DLRUD | OUDLC | CDER

Julian Chun
Pharmacist
DQCT | DRLB | DLRUD | OUDLC | CDER

 

 

Agenda

Visit CDER Small Business and Industry Assistance Page

 

P.Loebach

 

KEYNOTE SPEAKER

Paul Loebach
Branch Chief
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.

TOPICS COVERED

  • 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

FDA RESOURCES

INTENDED AUDIENCE

  • 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

 
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