A record in FDA drug approvals

In 2018, the FDA’s Center for Drug Evaluation and Research (CDER) hit a record number of approvals. A total of 59 novel drugs, including therapeutic molecules and biologicals, were approved1. The administration also approved 971 generics, including 190 tentative approvals2. Dr Nicola Davies discusses the potential impact of these approvals on various aspects of healthcare.

Impact on treatment

The highest number of novel drugs approved by the CDER were therapeutics for cancer (16), followed by infectious diseases (12), neurological disorders (8), and hematology (5) (Figure 1)3.