Zdrowie i gospodarka · 20/05/2014

FDA Announces Availability of Validation Rules for SEND Formatted Studies

The FDA's Center for Drug Evaluation and Research (CDER) has made the Validation Rules for Standard for Exchange of Nonclinical Data (SEND) Formatted Studies document available to enhance the standardization and quality of nonclinical data submitted to CDER, and to improve data predictability and usefulness.