Drugs

Drug Interactions: Relevant Regulatory Guidance and Policy Documents

Guidances

Clinical Drug Interaction Studies — Study Design, Data Analysis, and Clinical Implications Guidance for Industry

In Vitro Metabolism- and Transporter- Mediated Drug-Drug Interaction Studies Guidance for Industry

Other Related Clinical Pharmacology Guidances

  1. Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry (PDF - 92 KB) (Posted 12/01/16)
  2. Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications (PDF - 221 KB) (Posted 05/5/2003)
  3. Population Pharmacokinetics (PDF - 135 KB) (Posted 02/10/1999)
  4. Pharmacogenomic Data Submissions (PDF - 307 KB) (Posted 03/01/2005)

Labeling

  1. Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 144KB) (Posted 12/02/16)
  2. Labeling for Human Prescription Drug and Biological Products — Implementing PLR Content and Format Requirements (PDF - 527KB) (Posted 02/22/2013)
  3. 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)

Page Last Updated: 10/27/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English