Question

The investigational new drug (IND) application contains which of the following information? A. Toxicity of the test drug in humans B. Effectiveness of the test drug in humans C. Toxicity of the test drug in animals D. Safety and effectiveness of the test drug after FDA approval

Answer 1

Accelerated development/review (Federal Register, April 15, 1992) is a highly specialized mechanism for speeding the development of drugs that promise significant benefit over existing therapy for serious or life-threatening illnesses for which no therapy exists. This process incorporates several novel elements aimed at making sure that rapid development and review is balanced by safeguards to protect both the patients and the integrity of the regulatory process.