Please note for the following listed 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 web page https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

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

Drug-Drug Interaction Guidances for Industry

1. Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions (January 2020)
    
2. In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions (January 2020)
    
3. Drug-Drug Interaction Assessment for Therapeutic Proteins (August 2020)*
    
4. Clinical Drug Interaction Studies With Combined Oral Contraceptives (November 2020)*
    
5. Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications (November 2020)*

 

Other Related Clinical Pharmacology and Biopharmaceutics Guidances for Industry

1. Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications (May 2003)

2. Population Pharmacokinetics (July 2019)*

3. Pharmacogenomic Data Submissions (March 2005)

4. Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry (September 2018)

5. The Use of Physiologically Based Pharmacokinetic Analyses —Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls (September 2020)*

 

Labeling Guidances for Industry

See FDA’s Labeling Resources for Human Prescription Drugs

1. Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format (December 2016)

2. Labeling for Human Prescription Drug and Biological Products — Implementing PLR Content and Format Requirements (February 2013)

3. Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format (October 2011)

4. Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products (March 2010)

5. Labeling for Combined Hormonal Contraceptives (December 2018)*

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

Please note for the following listed 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) in Adobe Acrobat Format (PDF), check the FDA CDER Manual of Policies & Procedures web page: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-manual-policies-procedures-mapp.

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)