Where can I find information on whether or not I need to file an IND application for a biological product?
An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics License Application.
Our draft Guidance for Industry, Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND (PDF - 209KB) contains references to regulations, recommendations and helpful information to aid in the decision whether an IND may be required by FDA. The guidance includes the process for addressing inquiries concerning the application of IND requirements.