FDA TSE Advisory Committee Meeting October 25, 2001 Topic 2 Amino Acid Production and the Associated Theoretical Risk of BSE Transmission from their Use in the Production of Biologics, Drugs and Medical Devices

3/26/02


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Table of Contents

FDA TSE Advisory Committee Meeting October 25, 2001 Topic 2 Amino Acid Production and the Associated Theoretical Risk of BSE Transmission from their Use in the Production of Biologics, Drugs and Medical Devices

PPT Slide

Review of Tallow and Gelatin

Production of Amino Acids

Amino Acids in FDA-Regulated Drugs

Amino Acids in FDA-Regulated Drugs (cont)

Active Ingredients

Amino Acids in FDA-Regulated Drugs (cont)

Amino Acids in FDA-Regulated Drugs (cont)

Excipients and Reagents

Sponsors’ Responses to Request for Information

Suppliers’ Response to Request for Information

Amino Acid Manufacturers

Charge to the Committee

Charge to the Committee (cont)

Charge to the Committee (cont)

TSEAC 25 October, 2001 Topic 2: Safety of Amino Acids

TSEAC 25 October, 2001 Topic 2: Safety of Amino Acids

TSEAC 25 October, 2001 Topic 2: Safety of Amino Acids

TSEAC 25 October, 2001 Topic 2: Safety of Amino Acids