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Change Request
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Resolution: Persuasive
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Highest
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US Pharmaceutical Quality/Chemistry, Manufacturing and Controls (PQ-CMC) (FHIR)
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1.0.0-ballot
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Biomedical Research & Regulation
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Description and Composition of the Drug Product (3.2.P.1)
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Smita Hastak / Norman Gregory : 14 - 0 - 0
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Clarification
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Non-substantive
Explain how the strength and a dose form define a distinct Drug Product. Leverage definition from NDC that explains to dose form and strength
https://www.fda.gov/drugs/development-approval-process-drugs/national-drug-code-database-background-information
- is voted on by
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BALLOT-64730 Affirmative - CatherineHosage Norman : 2024-May-FHIR IG PQ CMC E1 STU
- Balloted