Drug Development and Drug Interactions:
Regulatory Guidance and Manual for Policies and Procedures

Guidances

Draft Guidance for Industry: Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling, replacing the 1997 in vitro metabolism guidance and 1999 in vivo metabolism guidance. Published for public comment September 2006.

• Federal Register Notice of Availability [HTML] [PDF]
• Guidance [HTML] [PDF]

Clinical Pharmacology

1. Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro (Issued 4/1997, Posted 4/8/1997); Updated draft guidance [HTML] [PDF]
2. Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications [Word] or [PDF] (Posted 5/5/2003)
3. In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations for Dosing and Labeling [HTML] or [PDF] (Issued 11/24/1999, Posted 11/24/1999); Updated draft guidance [HTML] [PDF]
4. Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling [Word] or [PDF] (Posted 5/30/2003)
5. Pharmacokinetics in Patients with Impaired Renal Function (Issued 5/14/1998, Posted 5/14/1998)
6. Population Pharmacokinetics (Issued 2/1999, Posted 2/10/1999)

Clinical Pharmacology (Draft)

1. Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling [HTML] or [PDF] or [Word] (Issued 2/7/05, Posted 2/8/05)
2. Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling [HTML] or [Word] or [PDF] (Issued 10/29/2004, Posted 10/29/2004)

1. Pharmacogenomic Data Submissions [HTML] or [Word] or [PDF] (Issued 3/2005, Posted 3/22/2005)
   • Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601 [HTML] or [Word] or [PDF] (Issued 3/2005, Posted 3/22/2005)

Labeling

1. Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format [HTML] or [PDF] (Issued 1/18/2006; Posted 1/18/2006)
2. Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format [HTML] or [PDF] (Issued 1/18/2006; Posted 1/18/2006)
3. Content and Format for Geriatric Labeling [HTML] or [PDF] (Issued 10/2001, Posted 10/4/2001)

Labeling (Draft)

1. Labeling for Combined Oral Contraceptives [PDF] or [Word] (Issued 3/2/2004, Posted 3/4/2004)
2. Labeling for Human Prescription Drug and Biological Products — Implementing the New Content and Format Requirements [HTML] or [Word] or [PDF] (Issued 1/18/2006; Posted 1/18/2006)
3. Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis) (Issued 6/1998, Posted 7/20/1998)
4. Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms--Recommended Prescribing Informtion for Health Care Providers and Patient Labeling [HTML] or [Word] or [PDF] (Issued 11/15/2005, Posted 11/15/2005)
5. Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications [HTML] or [PDF] (Issued 10/2000, Posted 10/25/2000)
6. Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format [HTML] or [Word] or [PDF] (Issued 1/18/2006; Posted 1/18/2006)

Manual for Policies and Procedures (MaPP)

Clinical Pharmacology and Biopharmaceutics Review Template, April 2004, http://www.fda.gov/cder/mapp/4000.4.pdf

Concept Papers

Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling, discussed at the FDA Advisory Committee for pharmaceutical sciences and Clinical Pharmacology Subcommittee meeting. Issues drug interaction concept paper. Rockville, MD. November 3, 2004;

• http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4079b1.htm;
• http://www.fda.gov/ohrms/dockets/ac/04/slides/2004-4079s1.htm
• http://www.fda.gov/ohrms/dockets/ac/04/transcripts/2004-4079T1.htm

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Date created: May 1, 2006
Date updated: October 11, 2006

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