Janssen&Janssen schreef op 17 maart 2023 22:25:
Novel Drug Approvals for 2023
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Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When it comes the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) provides clarity to drug developers on the necessary study design elements and other data needed in the drug application to support a full and comprehensive assessment. To do so, CDER relies on its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat.
Each year, CDER approves a wide range of new drugs and biological products:
Some of these products?have never been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products that CDER approved in 2023. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products that the Center for Biologics Evaluation and Research approved in 2023.
Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace. See Drugs@FDA for information about all of CDER’s approved drugs and biological products.
www.fda.gov/drugs/new-drugs-fda-cders...