Advancing Health Through Innovation – 2018 New Drug Therapy Approvals (2019) Center for Drug Evaluation and Research (CDER)

Description

An annual report summarizing the FDA Center for Drug Evaluation and Research’s (CDER) achievements in drug approvals for 2018. It highlights novel drugs, the use of expedited development and review pathways, biosimilars, new uses for existing drugs, and regulatory innovations aimed at improving patient access.