FDA Approvable Indications and Other Considerations
INTRODUCTION In selecting the appropriate and correct indication for your product candidate, whether it is a drug, biologic, or medical device it is extremely important to select one which is FDA approvable. The history of health care product development is filled with examples of potentially good products, which were studied for indications that FDA simply would not approve. This chapter will provide some guidance on selecting FDA approvable indications, along with examples of companies picking wrong indications, and the means to help you avoid making similar mistakes with candidate products. In addition, guidance in other areas related to FDA approvable indications are presented.