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1995S-0316
RPT 364
Volume 283

Cover Page

Letter dated October 19, 2006 from CFSAN to SK Chemical Co., Ltd.

Letter dated August 17, 2006 from Amin Law to CFSAN

Premarket Notification for New Dietary Ingredient: Clematis mandshurica

Exhibit A - Certificate of Good Manufacturing Practice from Korea Food and Drug Administration

Exhibit B - Certificate of Good Manufacturing Practice and Quality Standards

Exhibit C - Redacted

Exhibit D - Effect of SKI306X, a New Herbal Anti-Arthritic Agent, in Patients with Osteoarthritis of the Knee: a Double-Blinded Placebo Controlled Study Published Material

Exhibit E - A Four-Week Randomized, Double-Blind Trial of the Efficacy and Safety of SKI306X, an Herbal Anti-Arthritic Agent Versus Diclofenac in Osteoarthritis of the Knee

Exhibit F - Acute Toxicity of SKI306X, an Anti-inflammatory Herbal Extract, in Rats Published Material

Exhibit G - Subacute Toxicity of SKI306X, an Anti-inflammatory Herbal Extract, in Rats Published Material


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