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Archived Consultation on Draft Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)
The online consultation is now closed. The summary consultation report is available now. Health Canada wishes to thank participants who submitted comments. The content found on this page is a snapshot of the live consultation as it was presented to the public and contains the content that was open for submissions during the consultation period.
Notice of Subsequent Entry Biologics (SEB) May, 2008, consultation and draft guidance for comments.
The guidance document is being developed as part of a comprehensive regulatory framework for SEBs. This notice requests comments on the document in preparation for the upcoming May, 2008, consultation.
This notice also requests interested parties to express their interest in participating in the two-day consultation in May.
How to Get Involved
This consultation is open for comment starting March 14, 2008 until April 16, 2008. Please select and read through the link below titled "Draft Guidance Document". Once read please fill out the "Form for Comment" and "Expression of Interest" if interested in participating in the May, 2008 consultation. Please submit via email, or by fax to:
Special Projects Unit
Policy and Promotion Division
Biologics and Genetic Therapies Directorate
Health Canada
200 Tunney's Pasture Driveway
Ottawa ON, AL 0702A
K1A 0L2
Tel.: 613-946-5155
Fax: 613-952-5364
Interested parties are encouraged to provide comments and suggestions by April 16, 2008.
Reporting to Canadians
Health Canada will make the results of this consultation available on this Web site.
If you have any questions, contact us at BGTD_PPD_DPP@HC-SC.GC.CA.
