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Health Canada’s Request for Reconsideration Process: A Retrospective Analysis

Time

Mon, Jun 16 7:45AM
M 16

Title

Health Canada’s Request for Reconsideration Process: A Retrospective Analysis

Abstract Summary

A retrospective search through the SBD database was conducted to seek for cases of NOC that were granted subsequent to a RR. Corresponding NDA review packages from Drugs@FDA database were then retrieved to compare how HC and FDA tackled the scientific and regulatory issues in these submissions.

Poster Presenter

Lewis Lau
RAC,
Regulatory Affairs Associate,
Cynapsus
Canada