The purpose of preclinical work–animal pharmacology/toxicology testing–is to develop adequate data to undergird a decision that it is reasonably safe to proceed with human trials of the drug. After satisfactory information has been collected on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted, clinical trials are conducted to evaluate its safety and effectiveness in treating, preventing, or diagnosing a specific disease or condition. The results of this testing will comprise the single most important factor in the approval or disapproval of a new drug.
Although the goal of clinical trials is to obtain safety and effectiveness data, the overriding consideration in these studies is the safety of those in the trials. CDER monitors the study design and conduct of clinical trials to ensure that people in the trials are not exposed to unnecessary risks.
On this page you will find legal and ethical regulations and guidance that the US FDA published for the clinical trial of drug development on:
Regulatory Review IND
- Guidance for Industry: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 studies of Drugs, Including Well-Characterized, therapeutic, Biotechnology-derived Products
- Questions and Answers: Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products
- Exploratory IND Studies
Long-term /Reproductive Toxicity
- Guideline for Industry: the Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals
- Guidance on the Duration of Chronic Toxicity Testing in Animals (Rodent and Non-rodent Toxicity Testing); Availability
- Guideline for Industry Detection of Toxicity to Reproduction for Medicinal Products
- Reviewer Guidance: Integration of Study Results to Assess Concerns about Human Reproductive and Developmental Toxicities
In vivo Metabolism
- Guidance for Industry In Vivo Drug Metabolism/Drug Interaction Studies — Study Design, Data Analysis, and Recommendations for Dosing and Labeling