Regulation Text
Authority
21 U.S.C. 321,331,343,351,352,353,355,358,360,360b,360ccc,360ccc-1,360ddd,360ddd-1,360ee,360gg-360ss,371,374,379e;42 U.S.C. 216,241,262,264.
Related Guidelines (5)
Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Final)
→Clinical Development and Labeling of Anti-Infective Drug Products (Status: Final)
→Labeling for Human Prescription Drug and Biological Products - Implementing the PLR Content and Format Requirements (Status: Final)
→Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Small Entity Compliance Guide) (Status: Final)
→Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format: Draft Guidance for Industry (Status: Draft)
→