Special Considerations for Proprietary Name Review: Focus on Products That May Be Prescribed “As Directed”

Abstract

Prescriptions for these products with the signa "as directed" may not include product characteristics or other directions for use. The potential for products to be prescribed with the signa "as directed" should be taken into consideration when evaluating the safety of proposed proprietary names. Sponsors and the FDA can use the results of our research to aid in the selection and review of proposed proprietary names, respectively.