U.S. Food and Drug Administration | Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2024 – Part 1 @US_FDA | Uploaded 1 week ago | Updated 2 hours ago
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
00:51 – Keynote
12:06 – CDER Direct Establishment Registration Demo
43:04 – Establishment Registration Highlights
54:47 – Complying with Establishment Registration Requirements
01:07:48 – CDER Direct Labeler Code Request Demo
01:26:28 – Labeler Code Request Highlights
01:35:42 – Complying with Labeler Code Request Requirements
01:44:36 – Q&A Panel
Speakers | Panelists:
Matthew Lash, JD
Deputy Director
Office of Compliance
Center for Drug Evaluation and Research (CDER) | FDA
Regie Samuel
Technical Information Specialist
Drug Registration and Listing Branch (DRLB)
Division of Labeling, Registration, and Unapproved Drugs (DLRUD)
Office of Unapproved Drugs & Labeling Compliance (OUDLC)
CDER | FDA
Jose Cabrera
Technical Information Specialist
DRLB | DLRUD | OUDLC | CDER | FDA
Tasneem Hussain, PharmD
Consumer Safety Officer
DRLB | DLRUD | OUDLC | CDER | FDA
Puii Huber
Technical Information Specialist
DRLB | DLRUD | OUDLC | CDER | FDA
Laurie Simonds, GWCPM
Technical Information Specialist
DRLB | DLRUD | OUDLC | CDER | FDA
Vikas Arora, PharmD
Consumer Safety Officer
DRLB | DLRUD | OUDLC | CDER | FDA
Learn more at: fda.gov/drugs/news-events-human-drugs/electronic-drug-registration-and-listing-edrls-using-cder-direct-2024-09122024
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Upcoming Training - fda.gov/cdersbia
SBIA Listserv - public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2024 Playlist - youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g
SBIA LinkedIn - linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources - fda.gov/cdersbialearn
Twitter - twitter.com/FDA_Drug_Info
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
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
00:51 – Keynote
12:06 – CDER Direct Establishment Registration Demo
43:04 – Establishment Registration Highlights
54:47 – Complying with Establishment Registration Requirements
01:07:48 – CDER Direct Labeler Code Request Demo
01:26:28 – Labeler Code Request Highlights
01:35:42 – Complying with Labeler Code Request Requirements
01:44:36 – Q&A Panel
Speakers | Panelists:
Matthew Lash, JD
Deputy Director
Office of Compliance
Center for Drug Evaluation and Research (CDER) | FDA
Regie Samuel
Technical Information Specialist
Drug Registration and Listing Branch (DRLB)
Division of Labeling, Registration, and Unapproved Drugs (DLRUD)
Office of Unapproved Drugs & Labeling Compliance (OUDLC)
CDER | FDA
Jose Cabrera
Technical Information Specialist
DRLB | DLRUD | OUDLC | CDER | FDA
Tasneem Hussain, PharmD
Consumer Safety Officer
DRLB | DLRUD | OUDLC | CDER | FDA
Puii Huber
Technical Information Specialist
DRLB | DLRUD | OUDLC | CDER | FDA
Laurie Simonds, GWCPM
Technical Information Specialist
DRLB | DLRUD | OUDLC | CDER | FDA
Vikas Arora, PharmD
Consumer Safety Officer
DRLB | DLRUD | OUDLC | CDER | FDA
Learn more at: fda.gov/drugs/news-events-human-drugs/electronic-drug-registration-and-listing-edrls-using-cder-direct-2024-09122024
-----------------------
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Upcoming Training - fda.gov/cdersbia
SBIA Listserv - public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2024 Playlist - youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g
SBIA LinkedIn - linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources - fda.gov/cdersbialearn
Twitter - twitter.com/FDA_Drug_Info
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
