Latest news

Kinesis submits eCTD-IND for new combination product to FDA .

Kinesis has submitted an IND for a fixed dose combination product to the FDA. The submission consisted of information on the separate compounds, as well as information on the combination product. Part of the nonclinical and clinical studies on the combination product were entirely coordinated by the Kinesis team. For one of the compounds, a full nonclinical and clinical package based on studies, literature and postmarketing experience have been included to document the known safety profile of the compound. The IND has entirely been submitted in eCTD format.


Back to news overview

Print this page