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Specification:

US Pharmaceutical Quality/Chemistry, Manufacturing and Controls (PQ-CMC) (FHIR)
Raised in Version:

1.0.0-ballot
Work Group:

Biomedical Research & Regulation
Related Page(s):

Description and Composition of the Drug Product (3.2.P.1)
Grouping:
- Block-Vote-2
Resolution Description:

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Based on discussion with FDA internal team, it was decided that drug products with multiple strengths do not need to be submitted in a single P section in one bundle. There will be separate bundles for each strength/dose form.

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Based on discussion with FDA internal team, it was decided that drug products with multiple strengths do not need to be submitted in a single P section in one bundle. There will be separate bundles for each strength/dose form.
Resolution Vote:
Smita Hastak / Norman Gregory : 15 - 0 - 0

Consider adding all the drug products that would be submitted in a P section of eCTD 3.2 in one bundle.

is voted on by

BALLOT-64711 Affirmative - CatherineHosage Norman : 2024-May-FHIR IG PQ CMC E1 STU