This conference was 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.

Timestamps

01:55 – OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration

16:56 – National Drug Code (NDC) Reservation

32:37 – Format of the National Drug Code

50:35 – NDC Assignment to Drugs

01:03:55 – Untitled Letters and Warnings

01:12:12 – Data Inactivation

01:22:56 – Data Removals and Flags

01:31:22 – Downstream Effects

Speakers:

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

David Mazyck
Consumer Safety Officer
Drug Registration and Listing Branch (DRLB)
Division of Labeling, Registration and Unapproved Drugs (DLRUD)
Office of Unapproved Drugs and Labeling Compliance (OUDLC)
Office of Compliance (OC)
CDER | FDA

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

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

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

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

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

Learn more at: [ Ссылка ]

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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.

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