2021 in review: FDA approvals of new medicines.

By M. Kinch, Zachary Kraft, Tyler Schwartz. 2022

9 citations recorded by the source corpus.

The year 2021 witnessed a remarkable number of US Food and Drug Administration (FDA) approvals and registered clinical trials. In total, 60 new molecular entities (NMEs) were approved by the FDA, the highest level achieved in the post-Prescription Drug User Fee (PDUFA) era and tied with 2018. Of these NMEs, 49 used the incentives of the Orphan Drug Act or were approved under Priority, Fast-Track, Accelerated, and/or Breakthrough designations. Looking further, the number of registered clinical trials was off its 2020 record peak but well within the 5-year running average. Nonetheless, these remarkable outcomes were tempered by the fact that the rate of industry consolidation and turnover continued apace, reducing the number of organizations involved in the clinical development of new medicines and raising questions about long-term sustainability.

Subfields: Economics and Econometrics, Reproductive Medicine

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1. Wei Lu
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3. Jixian Zhang
4. Jiahua Rao
5. Chengtao Li
6. Shuangjia Zheng
7. Shuya Nakata
8. Gabriele Corso

Citations in the corpus

• TANKBind: Trigonometry-Aware Neural NetworKs for Drug-Protein Binding Structure Prediction (2022, background): “In 2021, FDA approved 60 new drugs, among which 36 were small molecules [1].”