Structured Product Labeling Project Update - PowerPoint PPT Presentation
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Structured Product Labeling Project Update
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Title: Collaborative Standards for Regulated Clinical Trials Author: LEVINR Last modified by: fda user Created Date: 3/4/2004 1:25:12 AM Document presentation format – PowerPoint PPT presentation
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Title: Structured Product Labeling Project Update
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Structured Product Labeling Project Update
HL7 Working Group meeting September 18, 2007
- Randy Levin, M.D.
- Director for Health and Regulatory Data Standards
- Food and Drug Administration
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Project Scope
- Device identification
- Differentiating product characteristics
- Veterinary medicine and other listing information
- Billing units
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Device Identification
- Available
- Unique device identifier
- Manufacturer
- Quantity
- Market approval number
- Indication
- Ingredient
- Device type
- Characteristics allergens, Single use or
reusable (and number of times), accessory - New
- Identifying numbers Model number, software
version, serial number, lot number - Expiration date
- Significant product modifications
- Device configuration
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Other Additions
- Differentiating characteristics
- Available
- Product differentiating characteristics
(freeness, flavors, allergens, metabolic
intolerances) - Veterinary medicine and other listing information
- Available
- Original text for dosage form
- Proprietary name suffix
- Original text for strength
- Clinical drug (e.g., RxNorm)
- New
- Basis of strength
- Therapeutic equivalent
- Billing units
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Model Changes
