PDS would like to inform our SEND community that the FDA, Center for Drug Evaluation and Research (CDER), is soliciting public comments related to a proposed Nonclinical Study Data Reviewer's Guide (SDRG) template developed by a PhUSE working group. FDA is seeking public comment to evaluate the template and determine whether the Agency will recommend its use either as is, or in a modified form, for regulatory SEND submissions of nonclinical study data.
The PhUSE working group that developed the template is co-chaired by PDS' own Laura Kaufman, PhD, DABT.
Todays Federal Register announcement, Intent to Review a Nonclinical Study Data Reviewer's Guide Template, and instructions for how to submit comments, can be found at:
PDS has been translating studies to the SEND standard for more than 10 years. We released the first publicly available, FDA-validated SEND 3.0 dataset, which was generated with our platform-agnostic SEND solution, TranSEND (TM). TranSEND is able to automatically populate the most recent PhUSE SDRG template and has been used for SEND submissions successfully received by the FDA from PDS clients spanning three continents.
Fur further information, please contact: SEND@pdslifesciences.com