Guidances
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Clinical Drug Interaction Studies — Study Design, Data Analysis, and Clinical Implications Guidance for Industry
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Other Related Clinical Pharmacology Guidances
- Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry (PDF - 92 KB) (Posted 12/01/16)
- Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications (PDF - 221 KB) (Posted 05/5/2003)
- Population Pharmacokinetics (PDF - 135 KB) (Posted 02/10/1999)
- Pharmacogenomic Data Submissions (PDF - 307 KB) (Posted 03/01/2005)
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Labeling
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- Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 144KB) (Posted 12/02/16)
- Labeling for Human Prescription Drug and Biological Products — Implementing PLR Content and Format Requirements (PDF - 527KB) (Posted 02/22/2013)
- Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 102KB) (Posted 10/11/2011)
Manual of Policies and Procedures (MaPP)
Good Review Practices: Clinical Pharmacology Review of New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) (PDF - 307KB) (Posted 09/22/16)
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