Concept Papers and Pharm/Tox
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Animal Models — Essential Elements to Address Efficacy Under the Animal Rule_09 (PDF - 135KB)
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Draft Guidance and Draft Concept Paper
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02/05/09
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Pharm/Tox
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Carcinogenicity Study Protocol Submissions (PDF - 29KB)
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Final Guidance
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05/22/02
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Clinical/Medical; Investigational New Drug Applications
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Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42KB)
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Final Guidance
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11/01/95
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Clinical/Medical; Investigational New Drug Applications
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Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products. Questions and Answers (PDF - 14KB)
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Final Guidance
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11/01/95
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Pharm/Tox
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Developing Medical Imaging Drug and Biological Products Part 1 Conducting Safety Assessments (PDF - 271KB)
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Final Guidance
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06/17/04
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Pharm/Tox
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Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers (PDF - 702KB)
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Final Guidance
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07/28/05
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Investigational New Drug Applications
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Exploratory IND Studies (PDF - 220KB)
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Final Guidance
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01/12/06
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Pharm/Tox
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Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application* (PDF - 1.3MB)
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Final Guidance
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02/01/87
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Pharm / Tox
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Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches (PDF - 169KB)
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Draft Guidance
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12/16/08
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Pharm/Tox
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Immunotoxicology Evaluation of Investigational New Drugs (PDF - 100KB)
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Final Guidance
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10/01/02
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Pharm/Tox
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Reproductive and Developmental Toxicities -- Integrating Study Results to Assess Concerns (PDF - 392KB)
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Final Guidance
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09/22/11
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Pharm/Tox
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Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals (PDF - 137KB)
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Final Guidance
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11/25/11
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Pharm/Tox
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Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal Contraceptives
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Final Guidance
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07/01/05
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Nonclinical Safety Evaluation of Drug or Biologic Combinations (PDF - 100KB)
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Pharm/Tox
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Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route (PDF - 76KB)
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Draft Guidance
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03/07/08
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Nonclinical Safety Evaluation of Pediatric Drug Products (PDF - 479KB)
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Pharm/Tox
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Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (PDF - 230KB)
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Final Guidance
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05/18/05
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Pharm/Tox
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Photosafety Testing (PDF - 179KB)
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Final Guidance
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05/07/03
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Pharm/Tox
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Recommended Approaches to Integration of Genetic Toxicology Study Results (PDF - 190KB)
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Final Guidance
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01/03/06
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Pharm/Tox
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Reference Guide for the Nonclinical Toxicity Studies of Antivial Drugs Indicated for the Treatment of N/A Non-Life Threatening Disease Evaluation of Drug Toxicity Prior to Phase I Clinical Studies (PDF - 837KB)
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Final Guidance
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03/02/98
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Pharm/Tox
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Safety Testing of Drug Metabolites (PDF - 86KB)
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Final Guidance
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02/14/08
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Pharm/Tox
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Single Dose Acute Toxicity Testing for Pharmaceuticals (PDF - 63KB)
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Final Guidance
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08/01/96
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Pharm/Tox
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Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals (PDF - 135KB)
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Draft Guidance
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05/08/01
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