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Conference | Virtual

Event Title
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2023
September 28, 2023


Date:
September 28, 2023
Time:
8:45 AM - 4:45 PM ET

Topics & Presentations

Speakers

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2023 – Part 1

 

Keynote.pdf

Jill Furman, JD
Director
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER) | FDA

How to Submit an Establishment Registration.pdf

Regie Samuel
Technical Information Specialist
Drug Registration and Listing Branch (DRLB)
Division of Labeling, Registration and Unapproved Drugs (DLRUD)
Office of Unapproved Drugs and Labeling Compliance (OUDLC)
OC | CDER | FDA

Using the Appropriate Business Operation(s) and Business Qualifier(s).pdf

Jose Cabrera
Information Technology Specialist
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Establishment Registration Renewal, Updates, and De-Registration.pdf

Regie Samuel

U.S. Agents and Official Contacts.pdf

Jose Cabrera

CDER Direct Labeler Code Request Demo.pdf

Soo Jin Park
LCDR, USPHS
Regulatory Officer
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Who Will Be Assigned a Labeler Code and Who Won’t.pdf

Laurie Simonds, GWCPM
Technical Information Specialist
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Labeler Code Inactivation and Reactivation.pdf

Lalnunpuii Huber
Technical Information Specialist
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Updates, Mergers, and Acquisitions.pdf

Laurie Simonds

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2023 – Part 2

 

CDER Direct Drug Listing.pdf

Troy Cu
Technical Information Specialist
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Listing a Combination Product.pdf

Troy Cu

Strength Conversion in Drug Listing.pdf

Leyla Rahjou-Esfandiary
Lead Consumer Safety Officer
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Listing Updates and Delisting.pdf

Yogesh Paruthi
Consumer Safety Officer
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Blanket No Change Certification.pdf

Vikas Arora
Pharmacist
DRLB | DLRUD | OUDLC | OC | CDER | FDA

503B Registration and Product Reporting Using CDER Direct.pdf

Huascar Batista
Senior Advisor
Office of Compounding Quality and Compliance (OCQO)
Office of Compliance (OC) | CDER | FDA

Q&A Discussion Panel

Troy Cu, Leyla Rahjou-Esfandiary, Yogesh Paruthi, Vikas Arora, Huascar Batista, Regie Samuel, Soo Jin Park, Laurie Simonds, and Lalnunpuii Huber

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2023 – Part 3

 

OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration.pdf

Yajun (Jason) Tu, PharmD, PhD, BCSCP
LCDR, USPHS
Program Management Officer
Policy and Operations Branch (POB)
Division of User Fee Management (DUFM)
Office of Management (OM) | CDER | FDA

National Drug Code (NDC) Reservation.pdf

David Mazyck
Consumer Safety Officer
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Format of the National Drug Code.pdf

Julian Chun
Pharmacist
DRLB | DLRUD | OUDLC | OC | CDER | FDA

NDC Assignment to Drugs.pdf

Soo Jin Park
LCDR, USPHS
Regulatory Officer
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Untitled Letters and Warnings .pdf                    

Tasneem Hussain
Pharmacist
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Data Inactivation.pdf

Vikas Arora
Pharmacist
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Data Removals and Flags.pdf

Tasneem Hussain

Downstream Effects.pdf

Leyla Rahjou-Esfandiary
Lead Consumer Safety Officer
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2023 – Part 4

 

Recent Automated Validation Rules.pdf

Lalnunpuii Huber
Technical Information Specialist
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Case Studies.pdf

Julian Chun
Pharmacist
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Q&A Discussion Panel

Lalnunpuii Huber, Julian Chun, Yajun (Jason) Tu, David Mazyck, Soo Jin Park, Tasneem Hussain, Vikas Arora, Leyla Rahjou-Esfandiary

 

Agenda

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS EVENT

This conference 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. FDA will provide:

  • A demonstration on how-to submit establishment registration and drug listing data using CDER Direct
  • An overview on registration and listing regulatory requirements and compliance framework
  • Case studies for an interactive learning experience at the end of the day

INTENDED AUDIENCE

  • Regulatory science and regulatory affairs professionals working on establishment registration and drug listing submissions and data compliance.
  • Consultants focused on SPL submissions to FDA.
  • Healthcare professionals using drug listing data and downstream databases to access prescribing and labeling information.
  • Foreign drug manufacturers and importers that manufacture and import drugs for US commercial distribution.

TOPICS COVERED

  • Explaining the latest proposed rule on the National Drug Code (NDC).
  • Learning about the current automated validation rules for registration and listing submissions.
  • Providing accurate registration and listing data to avoid submission errors, deficiency letters, manual overrides, and more.

LEARNING OBJECTIVES

  • Explain who must register and list.
  • Provide an overview to FDA’s registration and listing compliance program.
  • Explain how the strength conversion is calculated in listing SPLs.
  • Describe the formats and segments of the National Drug Code (NDC).

FDA RESOURCES

 

 
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