Drugs

Pharmacology / Toxicology

Below is a sortable table of Pharm/Tox guidances.

CategoryTitleTypeDate
Pharmacology / Toxicology Carcinogenicity Study Protocol Submissions (PDF - 29KB) Final Guidance 05/22/02
Clinical/Medical; Investigational New Drug Applications; Pharmacology/Toxicology Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42KB) Final Guidance 11/01/95
Clinical/Medical; Investigational New Drug Applications; Pharmacology/Toxicology Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products. Questions and Answers (PDF - 14KB) Final Guidance 10/01/00
Pharmacology / Toxicology Developing Medical Imaging Drug and Biological Products Part 1 Conducting Safety Assessments (PDF - 271KB) Final Guidance 06/17/04
Pharmacology / Toxicology Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers (PDF - 702KB) Final Guidance 07/28/05
Investigational New Drug Applications Exploratory IND Studies (PDF - 220KB) Final Guidance 01/12/06
Pharmacology / Toxicology Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application* (PDF - 1.3MB) Final Guidance 02/01/87
Pharmacology / Toxicology Immunotoxicology Evaluation of Investigational New Drugs (PDF - 100KB) Final Guidance 10/01/02
Pharmacology / Toxicology Reproductive and Developmental Toxicities -- Integrating Study Results to Assess Concerns (PDF - 392KB) Final Guidance 09/22/11
Pharmacology / Toxicology Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals (PDF - 137KB) Final Guidance 11/25/11
Pharmacology / Toxicology 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 Final Guidance 07/01/05
Pharmacology / Toxicology Nonclinical Safety Evaluation of Drug or Biologic Combinations (PDF - 100KB) Final Guidance
Pharmacology / Toxicology Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route (PDF - 153KB) Final Guidance 10/27/15
Pharmacology / Toxicology Nonclinical Safety Evaluation of Pediatric Drug Products (PDF - 479KB) Final Guidance
Pharmacology / Toxicology Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (PDF - 230KB) Final Guidance 05/18/05
Pharmacology / Toxicology Recommended Approaches to Integration of Genetic Toxicology Study Results (PDF - 190KB) Final Guidance 01/03/06
Pharmacology / Toxicology 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) Final Guidance 03/02/98
Pharmacology / Toxicology Safety Testing of Drug Metabolites (PDF - 86KB) Final Guidance 02/14/08
Pharmacology / Toxicology Single Dose Acute Toxicity Testing for Pharmaceuticals (PDF - 63KB) Final Guidance 08/01/96
Pharmacology / Toxicology Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals (PDF - 135KB) Draft Guidance 05/08/01
Pharmacology / Toxicology Nonclinical Evaluation of Endocrine-Related Drug Toxicity (PDF - 129KB) Final Guidance 09/08/15
Pharmacology/Toxicology Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment (PDF - 179KB) Draft Guidance 05/12/15
Pharmacology / Toxicology Assessment of Male- Mediated Developmental Risk for Pharmaceuticals Guidance for Industry (PDF - 218KB) Draft Guidance 06/11/15
Clinical / Medical; Pharmacology / Toxicology Testicular Toxicity: Evaluation During Drug Development Guidance for Industry (PDF - 302KB) Draft Guidance 07/16/15

Page Last Updated: 05/27/2016
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