November 4

CVM Update - FDA Evaluates Test Kits to Detect Animal Proteins in Animal Feed, November 4, 2004

November 3

CVM Update - FDA Approves Rumensin® for Increased Milk Production Efficiency in Dairy Cows, November 3, 2004

Current Label - Rumensin® Monensin Granulated, USP 80 (pdf)

November 1

VMAC Fall 2004 Public Meeting Presentations

October 28, 2004

International Workshop on Minor Use and Minor Species (MUMS): Speaker Bios

International Workshop on Minor Use and Minor Species (MUMS): Presentations

CVM Update - FDA Permits the Use of Selenium Yeast in Horse Feed, October 14, 2004

Draft Guidance for Industry 105 - Computerized Systems Used in Clinical Trials, Revision 1,Erratum, September 2004 [pdf] [html]

Federal Register Notice: - Docket No. 2004D-0440, CDER 2003195.  Draft Guidance for Industry on Computerized Systems Used in Clinical Trials; Availability.  Pages  59239-59240 [FR Doc. 04-22204]  October 4, 2004 [TXT] [PDF] Comments due January 3, 2005

The Draft Guidance (PDF)
The Draft Guidance (Word)
Erratum

Final Agenda - International Workshop on Minor Use and Minor Species (MUMS): A Global Perspective,

Federal Register Notice - Docket No. 2003D-0380, CDER 2004106.  Guidance for Industry: Process Analytical Technology--A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance; Availability.  Pages  59257-59258 [FR Doc. 04-22203] October 4, 2004 [TXT] [PDF] [PRE-PUB]
Comments due October 4, 2005 The Guidance (PDF) The Guidance (Word)

Guidance Document - Guidance for Industry - PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, September 2004
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