U.S. New Drug Application & FDA Approvals → FDA Approval Process

Timeline: The goal is for the FDA to get the drug candidate through the approval process in around six months. An accelerated approval pathway exists for drugs used in serious or life-threatening illnesses that do not already have adequate treatment.

CDER: FDA’s Center for Drug Evaluation and Research (CDER) evaluates evidence from clinical and nonclinical tests. A team of physicians, statisticians, chemists, pharmacologists, and other scientists review data and proposed labeling to determine safety and efficacy of the drug.

• CBER reviews biologic drug applications presented in a BLA the same way CDER reviews small molecule drugs presented in an NDA.