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  6. Drug Interactions | Relevant Regulatory Guidance and Policy Documents
  1. Drug Interactions & Labeling

Drug Interactions | Relevant Regulatory Guidance and Policy Documents

FDA Guidances for Industry

Guidance documents represent the Agency's current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. For information on a specific guidance document, please contact the originating office.  Another method of obtaining guidance documents is through the Division of Drug Information.

We update guidances periodically. For the most recent version of a guidance, check the FDA guidance page. 

Drug-Drug Interaction Guidances for Industry

  1. M12 Drug Interaction Studies (August 2024)
  2. Drug-Drug Interaction Assessment for Therapeutic Proteins (June 2023)
  3. Clinical Drug Interaction Studies With Combined Oral Contraceptives (June 2023)
  4. Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications (March 2023)

Other Related Clinical Pharmacology and Biopharmaceutics Guidances for Industry

  1. Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry (March 2024)
  2. Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics (June 2024)
  3. Pharmacogenomic Data Submissions (March 2023)*
  4. Population Pharmacokinetics (February 2022)
  5. The Use of Physiologically Based Pharmacokinetic Analyses —Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls (September 2020)*
  6. Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry (September 2018)
  7. Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications (May 2003)

*When final, this guidance will represent the Agency’s current thinking on this topic.

Labeling Guidances for Industry

See FDA’s Labeling Resources for Human Prescription Drugs

  1. Drug Interaction Information in Human Prescription Drug and Biological Product Labeling (October 2024)*
  2. Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products (January 2023)*
  3. Labeling for Combined Hormonal Contraceptives (December 2018)*
  4. Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format (December 2016)
  5. Labeling for Human Prescription Drug and Biological Products — Implementing PLR Content and Format Requirements (February 2013)
  6. Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format (October 2011)

*When final, this guidance will represent the Agency’s current thinking on this topic.

CDER Manual of Policies and Procedures

CDER's Manual of Policies and Procedures (MAPPs) are federal directives and documentation of internal policies and procedures. MAPPs are required by law, and made available to the public to make CDER a more transparent organization. For the most current CDER Manual of Policies and Procedures (MAPPs), check the FDA CDER Manual of Policies & Procedures page.

Manual of Policies and Procedures (MAPP)

  1. MAPP 4000.4 Rev 1: Good Review Practices: Clinical Pharmacology Review of New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) (September 2016)
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