DIA
Drug Information Association Logo

Regulatory CMC BLA and NDA Submissions: Differences and Correlations from Regulatory and Scientific Perspectives

Time

Wed, Jun 27 11:00AM
W 14

Title

Regulatory CMC BLA and NDA Submissions: Differences and Correlations from Regulatory and Scientific Perspectives

Abstract Summary

Based on regulatory CMC dossier preparation experience for both biologics and chemical drugs, the major differences in regulatory requirements and level of details are compared for BLAs and NDAs. The emphasis is on the correlations between the sections where major differences exist.

Poster Presenter

David Donne
PhD,
Associate Director,
Janssen Pharmaceuticals Companies of Johnson & Johnson
United States

© 2015 DIA