News

Di, 2020-02-11 09:53
Are you prepared? How to successfully  implement the transition from Promotional Material Submissions to eCTD
Are you prepared? In June 2021, 2253 Promotional Material and Accelerated Approval Product submissions are mandated to be submitted through eCTD. While there are other types of promotional materials, only two are subject to the electronic mandate according to the electronic requirement in section 745A(a) of the FD&C Act. Will you be prepared to make the change?
Mi, 2018-04-25 15:42
As of May 5, 2018, the FDA will only accept electronic submission and arivis Inc. is here to help!