SBIA, in collaboration with the Drug Registration and Listing Branch (DRLB) in the Office of Compliance (OC), hosted its annual Electronic Drug Registration and Listing (eDRLS) Annual Conference 2024. This year’s event included an overview on registration and listing regulatory requirements and compliance framework, as well as demos and case studies for an interactive learning experience. Additionally, faculty discussed OTC drug listing requirements and its relation to the OTC Monograph Drug User Fee Program (OMUFA) assessment.

Timestamps

01:11 – CDER Direct Drug Listing Demo

25:04 – Listing Updates and Blanket “No Changes” Certification Demo

39:37 – Drug Listing Highlights

53:47 – Complying with Drug Listing Requirements

01:05:35 – NDC Reservation

01:17:26 – Future Format of the National Drug Code

01:27:36 – NDC Assignment to Drugs

01:40:05 – OTC Drug Listing Updates and Validation

01:50:50 – Drug Amount Reporting for Listed Drugs

02:01:19 – Who Should Not Register or List

02:08:53 – Case Studies

02:24:10 – Q&A Panel

Speakers | Panelists:

Troy Cu
Technical Information Specialist
Drug Registration and Listing Branch (DRLB)
Division of Labeling, Registration, and Unapproved Drugs (DLRUD)
Office of Unapproved Drugs & Labeling Compliance (OUDLC)
Center for Drug Evaluation and Research (CDER) | FDA

Yogesh Paruthi, PharmD
Consumer Safety Officer
DRLB | DLRUD | OUDLC | CDER | FDA

Vikas Arora, PharmD
Consumer Safety Officer
DRLB | DLRUD | OUDLC | CDER | FDA

Tasneem Hussain, PharmD
Consumer Safety Officer
DRLB | DLRUD | OUDLC | CDER | FDA

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

Leyla Rahjou-Esfandiary, PharmD
Branch Chief
DRLB | DLRUD | OUDLC | CDER | FDA

Soo Jin Park, PharmD, MS
Lieutenant Commander | United States Public Health Service (USPHS)
Regulatory Officer
DRLB | DLRUD | OUDLC | CDER | FDA

Obinna Ugwu-Oju, MS
Division Director
Office of Pharmaceutical Quality (OPQ)
Office of Quality Surveillance (OSI)
CDER | FDA

Yogesh Paruthi, PharmD
Consumer Safety Officer
DRLB | DLRUD | OUDLC | CDER | FDA

Julian Chun, PharmD, MBA
Consumer Safety Officer
DRLB | DLRUD | OUDLC | OC | CDER | FDA

Learn more at: https://www.fda.gov/drugs/news-events...

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