Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2024 - Part 2
Рет қаралды 561
Күн бұрынSBIA, 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: www.fda.gov/dr...
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