US FDA explains which human studies do not need an IND
This article was originally published in SRA
The US Food and Drug Administration has issued draft guidance to explain what types of human research studies can be carried out without filing an investigational new drug (IND) application1,2.
You may also be interested in...
Drug companies in the EU explain how a new pilot scheme on national-level scientific advice service can benefit drug developers.
While the Dutch government negotiates an acceptable price for Leadiant Biosciences’ orphan drug CDCA, a university hospital has resumed supplying pharmacy compounded versions of the drug after addressing initial problems with the sourcing of raw materials.
The European Court of Justice has confirmed the European Medicines Agency’s approach to disclosure of data submitted as part of a marketing authorization application. It is a big disappointment for industry, which nonetheless says it supports responsible data sharing and will support efforts to develop a balanced approach.