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THE RIGHT TREATMENT | FOR THE RIGHT PATIENT | AT THE RIGHT TIME | EVERY TIME
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FDA CDER Announces the Availability of an Inventory of Drug Development Contexts for Streamlined Nonclinical Programs |
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On October 8, 2025, the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) released a new table to support the use of new approach methodologies (NAMs) and reduction of animal use. The table contains an inventory of drug development contexts for which CDER is open to a streamlined nonclinical program. Streamlined nonclinical programs include but are not limited to reduced sample size, reduced number of species tested, and NAMs use. The table provides general information; sponsors should consult guidance documents and appropriate FDA review divisions for more information. The FDA regularly revises existing guidance documents and publishes new guidance documents. This table will be updated as new information becomes available.
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The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today or click the button below and select Clinical Pharmacology Corner under Drugs.
We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.
This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.
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