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


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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 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

bovine components in cder regulated products
Bovine Components in CDER-Regulated Products
  • Active Ingredients
  • Excipients
  • Reagents
active ingredients
Active Ingredients
  • Glucagon (pancreas)
  • Aprotinin (lung)
  • Heparin (lung)
  • Collagen (cartilage)
  • Amino Acids (various sources)
excipients
Excipients
  • Gelatin (bone)
  • Amino Acids (various sources)
  • Glycerin (tallow)
  • Polysorbate 80 (tallow)
reagents
Reagents
  • Bovine Serum (blood)
  • Protein A (blood)
  • Human Transferrin (blood)
  • Amino Acids (various sources)
assessment of risk
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)
management of risk
Management of Risk
  • Industry letters
  • FR Notices
  • Industry guidance (gelatins)
  • MAPPs (ONDC)
  • Application review
  • Tracking systems
  • Risk assessment plan
management of risk cont
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
management of risk cont active ingredients
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
management of risk cont excipients
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)
management of risk cont reagents
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
ongoing activities
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