Have a look at this infographic that Extedo® and Asphalion have prepared with the summary updates in terms of publishing and eSubmission at a regional level, focused on INDs for US FDA!
The US law requires that a drug be the subject of an approved marketing application before it is transported across state lines, e.g., to clinical investigators. The IND is the way for the sponsor to get this exemption from the FDA. So, before a new drug in a preclinical development status can be used for clinical studies, an IND has to be submitted.
ASPHALION and our partner Extedo® can offer you a wide range in Regulatory Services and Solutions in the United States. Asphalion can support you throughout the whole lifecycle of the IND procedure in a variety of activities.
Check the document here:
