In the United States, new pharmaceutical products must be approved by the Food and Drug Administration (FDA) as being both safe and effective. This process generally involves submission of an Investigational New Drug filing with sufficient pre-clinical data to support proceeding with human trials. Following IND approval, three phases of progressively larger human clinical trials may be conducted. Phase I generally studies toxicity using healthy volunteers. Phase II can include pharmacokinetics and dosing in patients, and Phase III is a very large study of efficacy in the intended patient population. Following the successful completion of phase III testing, a New Drug Application is submitted to the FDA. The FDA review the data and if the product is seen as having a positive benefit-risk assessment, approval to market the product in the US is granted. COUNT 5
QSN1 The safety and efficacy of new drugs must be approved by what organization in the US? ANS1 Food and Drug Administration QSN2 What type of filing is used before beginning human trials? ANS2 Investigational New Drug QSN3 How many phases of human trials may be done after IND approval? ANS3 three QSN4 What type of application is filed after completing three phases of human trials? ANS4 New Drug Application QSN5 What type of risk assessment results in approving the drug to go on the market? ANS5 positive benefit-risk