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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Draft Guidance for Industry: Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling, replacing the 1997 in vitro metabolism guidance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
- 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(Issued 4/1997, Posted 4/8/1997); Updated draft guidance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]
- Exposure-Response Relationships — Study Design, Data Analysis, and
Regulatory Applications [Word] or [PDF]
(Posted 5/5/2003)
- 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11/24/1999, Posted 11/24/1999); Updated draft guidance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]
- Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design,
Data Analysis, and Impact on Dosing and Labeling [Word]
or [PDF] (Posted 5/30/2003)
- Pharmacokinetics in
Patients with Impaired Renal Function
(Issued 5/14/1998, Posted 5/14/1998)
- Population
Pharmacokinetics (Issued 2/1999, Posted 2/10/1999)
Clinical Pharmacology (Draft)
- Clinical Lactation Studies--Study Design, Data Analysis, and
Recommendations for Labeling [HTML] or [PDF] or [Word]
(Issued 2/7/05, Posted 2/8/05)
- 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)
Procedural
- 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
- 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)
-
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)
- Content and Format for Geriatric Labeling [HTML] or [PDF] (Issued 10/2001, Posted 10/4/2001)
Labeling (Draft)
- Labeling for Combined Oral Contraceptives
[PDF] or [Word]
(Issued 3/2/2004, Posted 3/4/2004)
- 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)
- Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal
Yeast Infections (Vulvovaginal Candidiasis)
(Issued 6/1998,
Posted 7/20/1998)
- 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)
- Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug
Applications [HTML]
or [PDF] (Issued
10/2000, Posted 10/25/2000)
- 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;
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Date created: May 1, 2006
Date updated: October 11, 2006 |
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