“The Food and Drug Administration (FDA) is creating a pilot program to test new data standards for the data collected in non-clinical studies funded by the agency, FDA announced in an upcoming Federal Register post.”
“The post, released for public inspection on August 19, notes that FDA is deciding whether to extend the Standard for Exchange of Nonclinical Data (SEND) 3.1, created by the Clinical Data Interchange Standards Consortium (CDISC). FDA’s Center for Drug Evaluation and Research (CDER) is specifically looking to apply SEND 3.1 to nonclinical toxicology data…” Read the full article here.
Source: FDA Piloting New Data Standards for Studies – August 19, 2019. MeriTalk.
