The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has published its report on new drug approvals in 2022, Advancing Health Through Innovation: New Drug Therapy Approvals.
The report highlights new drugs never before approved or marketed in the USA, as well as drugs being used in new settings, such as for new uses and new patient populations. The report also illustrates the ways CDER evaluated drug safety and efficacy, as well as the regulatory tools used to review and approve drug applications.
For the whole of 2022, the FDA cleared 37 new drugs, as defined above, for approval to be marketed in the USA. This was down from 50 in 2021 and 53 in 2020.
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