About

The drug registration and listing staff hosted a workshop dedicated to assisting industry with creating complete and accurate registration and listing submissions. This year focused on the top errors and mistakes observed with submissions and highlighted FDA’s newly announced process for inactivation of uncertified listings.

Topics Covered

Drug registration and listing compliance program featuring a case study of a violation
Registration and labeler code requests
NDC reservation, drug listing, and 503B compounder product reporting
Listing certification and FDA inactivation of uncertified listings
Town hall with the DRLS staff

Intended Audience

Regulatory affairs professionals working on registration and listing or who submit Structured Product Labeling (SPL) to FDA
Members of Industry who submit Registration and Listing
US Agents for Foreign registrants
Importers and import agents
Consultants and law firms representing pharmaceutical companies

Keynote FDA Speaker

Paul Loebach, Director
Drug Registration and Listing Staff | Office of Program and Regulatory Operations CDER | FDA

FDA Resources

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Electronic Drug Registration and Listing Using CDER Direct - 10/22/2019

Distribution channels: Healthcare & Pharmaceuticals Industry

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