What is the Investigational New Drug (IND) process?
Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND, or Investigational New Drug application, is the means through which the sponsor technically obtains this exemption from the FDA.
Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND, or Investigational New Drug application, is the means through which the sponsor technically obtains this exemption from the FDA.
Related Questions
- Will the DCC prepare investigational new drug (IND) applications for Specialized Center clinical studies or will the DCC provide advice with a Specialized Centers on how to prepare an IND application?
- Where should I send my Investigational New Drug application (IND) submission?
- What is the Investigational New Drug (IND) process?
