What's New

Files added to the Web site are also posted here in the What's New section for three weeks. Once you have browsed through the entire site, all you need to do to keep current is make sure you visit this page more than once every three weeks. The files will be available for downloading from here, and also have a link to the section in which they permanently live.

Weekly Drug NOC updates: November 12 - 16, 2007

Added on November 22, 2007

Register of Innovative Drugs Register of Innovative Drugs

Added on November 20, 2007

Quarterly Reports Therapeutic Products Directorate (TPD) - 2007 Quarterly Drug Submission Performance Report - Part I Biologics and Genetic Therapies Directorate (BGTD) - 2007 Quarterly Drug Submission Performance Report - Part II

Added on November 15, 2007

Added on November 14, 2007

Summary Basis of Decision: Phase 1 Summary Basis Of Decision (SBD) ORTHO T. CRUZI ELISA TEST SYSTEM Package Insert for ORTHO T. CRUZI ELISA TEST SYSTEM

Canada Gazette Part II Food and Drug Regulations - Project 1491 - Schedule F Addition (SOR/2007-224) Food and Drug Regulations - Project 1478 - Schedule F Addition (SOR/2007-224) Food and Drug Regulations - Project 1512 - Schedule F Additions (SOR/2007-234) Food and Drug Regulations - Project 1511 - Schedule F Addition (SOR/2007-234) Food and Drug Regulations - Project 1502 - Schedule F Additions (SOR/2007-234) Food and Drug Regulations - Project 1476 - Schedule F Additions (SOR/2007-234)

Added on November 13, 2007

	eCTD Health Canada posts validation rules for submissions provided in the eCTD format
	Summary Basis of Decision: Phase 1 Notice of decision for AVAMYS

Added on November 8, 2007

Good Review Practices Standard Operating Procedures (SOP) - Using the Pharmaceutical Safety and Efficacy Assessment Template (PSEAT) to Prepare Reports on Periodic Safety Update Reports for Products Authorized under the Notice of Compliance with Conditions Policy (PSUR-C)

Added on November 6, 2007

Summary Basis of Decision: Phase 1 Notice of decision for CUBICIN

Added on November 5, 2007

Summary Basis of Decision: Phase 1 Summary Basis of Decision (SBD) LYRICA Product Monograph Part III LYRICA

Added on October 31, 2007

Good Guidance Practices

Added on October 30, 2007

Summary Basis of Decision: Phase 1 Notice of decision for ATRIANCE

Added on October 25, 2007

Metabolic and Endocrine Therapies Membership list

Added on October 25, 2007

	Notice of Compliance with conditions (NOC/c) Atriance Fact Sheet Dear Health Care Professional Letter Qualifying Notice
	Metabolic and Endocrine Therapies Agenda

Added on October 22, 2007

Metabolic and Endocrine Therapies Announcement of meeting and invitation for stakeholder comments