FDA prescription labeling uses narrative Pregnancy and Lactation Labeling Rule sections rather than the former A/B/C/D/X letter categories.
- Public-source certainty descriptor
- high for US regulatory framework
- Formal appraisal
- Not started — full text and independent appraisal pending
- Exposure window
- pregnancy and lactation
- Comparator
- not applicable
No reliable quantitative estimate.
Exact labeling and revision date remain product-specific; non-US systems differ.
Sources, citation controls, and verification state
Linked sources
- regulatory frameworkEXT-046 · Not formally appraised
- Pregnancy and Lactation Labeling Rule resourcesR-FDA-PLLR · Final rule 2014; effective 2015-06-30 · Current framework
- PMID
- Not populated in v0.95
- DOI
- Pending DOI verification
- Exact locator
- Pending exact table/figure/page/supplement locator
- Access date
- 2026-07-29
- Integrity check
- Same-day source surveillance recorded; source-by-source correction/retraction verification remains pending
- Internal verification
- Source-linked; independent external verification pending