CE Mark IDE
CPA NDA
510k BLA
CTA PMA
IND Ethics submissions

 

An Investigational New Drug Application (IND) is a request for authorisation from the Food and Drug Administration (FDA) in the USA  to administer an investigational drug or biological product to humans. Such authorisation must be secured prior to shipment and administration of any new drug or biological product which is not the subject of an approved New Drug Application or Biologics/Product Licence Application, into or between states in the USA.