Health Canada issues draft guidelines on follow-on biologics

03/24/2008 | FDAnews

Health Canada has issued preliminary guidance for companies seeking approval for "subsequent-entry biologics," the government's first step toward allowing the sale of follow-on versions of biotech drugs. The agency, which plans to publish more guidelines for specific biologic product classes, says existing laws authorize it to clear subsequent-entry products until legislation creates a new approval path.

View Full Article in:

FDAnews

Published in Brief:

SmartBrief Job Listings for Health Care

Job Title Company Location
Counsel – Regulatory Affairs
RAI Services Company
Winston Salem, NC
Director of Program Development
AdvaMed
Washington DC, DC
Director of System QA
LifeWatch Services, Inc.
Rosemont, IL
Director of Business Development and Membership
AdvaMed
Washington DC, DC
Director, Corporate Counsel
Regeneron
Tarrytown, NY