Supporting Your Claims: Recent Issues in Cardiovascular Drugs

Abstract

Aside from technical problems which may impede the reviewing process, approval of a new drug depends on whether the clinical data support the claims of efficacy and safety. Using several recent new drug applications (NDAs) of cardiorenal drugs as examples, it is argued that to successfully support a claim, meeting minimal requirements in the current clinical guidelines may be necessary but not sufficient, and excessive dissection and manipulation of data must be avoided. In addition, assessment of safety and tolerability data is also required for formulating an efficacy claim. These important issues in packaging a successful application are discussed from the perspective of a Food and Drug Administration (FDA) secondary reviewer.