Is an Investigational New Drug Application Required?
An investigator is always required to submit an Investigational New Drug (IND) application to study an unmarketed (i.e. unapproved) medical drug or biologic. An investigator may be required to submit an IND application to the FDA in order to study a marketed medical drug or biologic in a new (i.e. unapproved) clinical indication. In both cases, the products are considered “investigational” by the FDA.
For guidance on how to proceed for your unmarketed drug or biologic, or to determine if an IND application must be submitted to study a marketed drug or biologic, click here to request a consultation from our team of experts.