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FDA TSE Advisory Committee Meeting February 13, 2004; Topic 4D Minimizing the Risk of TSE in CDER - Regulated Products

FDA TSE Advisory Committee Meeting February 13, 2004; Topic 4D Minimizing the Risk of TSE in CDER - Regulated Products. Gerald M. Feldman, Ph.D. Division of Monoclonal Antibodies Office of Biotechnology Products Office of Pharmaceutical Science Center for Drug Evaluation and Research.

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FDA TSE Advisory Committee Meeting February 13, 2004; Topic 4D Minimizing the Risk of TSE in CDER - Regulated Products

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  1. FDA TSE Advisory Committee MeetingFebruary 13, 2004; Topic 4D Minimizing the Risk of TSE in CDER -Regulated Products Gerald M. Feldman, Ph.D. Division of Monoclonal Antibodies Office of Biotechnology Products Office of Pharmaceutical Science Center for Drug Evaluation and Research

  2. Bovine Components in CDER-Regulated Products • Active Ingredients • Excipients • Reagents

  3. Active Ingredients • Glucagon (pancreas) • Aprotinin (lung) • Heparin (lung) • Collagen (cartilage) • Amino Acids (various sources)

  4. Excipients • Gelatin (bone) • Amino Acids (various sources) • Glycerin (tallow) • Polysorbate 80 (tallow)

  5. Reagents • Bovine Serum (blood) • Protein A (blood) • Human Transferrin (blood) • Amino Acids (various sources)

  6. Assessment of Risk • Source Country • High or low risk tissues/organs • Proposed use of material ( e.g. active, excipient vs. starting material) • Inactivation by the manufacturing process (e.g. high temp for glycerol)

  7. Management of Risk • Industry letters • FR Notices • Industry guidance (gelatins) • MAPPs (ONDC) • Application review • Tracking systems • Risk assessment plan

  8. Management of Risk (cont) • Prohibition of use of raw materials originated from countries with known BSE or considered at risk (with specific exceptions) • Changing to non-animal derived ingredients and reagents where feasible

  9. Management of Risk (cont):Active Ingredients • Restriction • In compliance with 1996 FDA Policy • No bovine-derived components from BSE positive/high risk countries • No restriction on other ruminant sources • Exemptions • Milk-derived • Hide/Hair-derived

  10. Management of Risk (cont): Excipients • Restriction • In compliance with 1996 FDA Policy • No bovine-derived components from BSE positive/high risk countries • No restriction on other ruminant sources • Exemptions • Gelatin (with caveat) • Tallow derivatives (with caveat)

  11. Management of Risk (cont): Reagents • Restriction • In compliance with 1996 FDA Policy • No bovine-derived components from BSE positive/high risk countries • No restriction on other ruminant sources • Exemptions • Master cell banks • Amino acids

  12. Ongoing Activities • No official action taken in response to the single case of BSE in US • Proposed regulations on current TSE/BSE policies (pending) • Revision to the Gelatin Guidance (pending) • Continued tracking of materials

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