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

01:13 – CDER Direct Drug Listing

23:35 – Listing a Combination Product

33:20 – Strength Conversion in Drug Listing

43:03 – Listing Updates and Delisting

49:32 – Blanket No Change Certification

01:00:58 – 503B Registration and Product Reporting Using CDER Direct

01:17:36 – Q&A Discussion Panel

Speakers:

Troy Cu
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)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER) | FDA

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

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

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

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

Panelists:

Troy Cu, Leyla Rahjou-Esfandiary, Yogesh Paruthi, Vikas Arora, Huascar Batista

And

Regie Samuel
Technical Information Specialist
DRLB | DLRUD | OUDLC | OC | CDER | FDA

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

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

Lalnunpuii Huber
Technical Information Specialist
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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Phone - (301) 796-6707 I (866) 405-5367

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