The Food and Drug Administration (FDA) is in charge of pharmaceutical industry law in order to protect public health.  The FDA’s objective isn’t simply to ensure that high criteria for drug efficacy and safety are met by products and patients, but also to balance the lengthy, costly process of maintaining these standards against the need to provide access to effective therapies sooner and with less outlays. New medicine and device approval takes an average of 12 and 7 years, respectively, from pre-clinical study to approval. Medical device development costs millions of dollars, and a recent study shows that the total cost of a new medicine exceeds $1 billion. FDA processes can be daunting for investigators seeking approval for new drugs and devices.

Between 2018 and 2021, 221 novel drugs approved by the US Food and Drug Administration (FDA) were assessed based on approval numbers by year, active ingredients, modalities, mode of administration, approval times, and accelerated assessment classifications.

Notwithstanding the changes wrought by COVID-19, the FDA’s Center for Drug Evaluation and Research (CDER) accepted 50 new medicines in 2021.

Some of these products have never been tested in humans. The following is a list of novel molecular entities and therapeutic biological products approved by the CDER in 2021. Vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, and other products approved by the Center for Biologics Evaluation and Research in 2021 are not included in this list.

References:

1. Novel Drug Approvals  for 2021. Created 01/06/2022 https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2021
2. Gail A. Van Norman. Accepted 10 March 2016. https://www.sciencedirect.com/science/article/pii/S2452302X1600036X