General Principles of Pharmacology

A New Drug Application (NDA) is submitted after Eie investigation of Eie drug in Biases I, II, and III is 

Rgure 1 -1. Phases of drug development. Adapted from (1997, ring) PharmFhax, 3 (2), 2. 

The Oqihan Drug Act of 1983 was jiassed to encourage die development and marketing of products used to treat rare diseases. The act defines a rare disease as a condition affecting fewer than 200,000 individuals in die United States. The National Organization of Rare Disorders reports that there are more diaii 6000 rare disorders that affect iproximately 25 million individuals. Examples of rare disorders include Tourette s syndrome, ovarian cancer, acquired immunodeficiency syndrome (AIDS), Huntington s disease and certain forms of leukemia 

Accelerated approval of dru is offered by die FDA as a means to make promising products for life-direatening diseases available on die market, based on preliminary evidence before fonnal demonstration of patient benefit. 

Nurses play an important role in monitoring for adverse reactions. The FDA considers serious adverse reactions those that may result in death, life-threatening illness, hospitalization, or disability or those that may require medical or surgical intervention. 

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