Parallel Track IND

The FDA’s Parallel Track policy permits wider access to new drugs for life-threatening diseases under a separate treatment protocol (Parallel Track IND) that “parallels” the controlled Phase II and III clinical trials performed to establish the safety and effectiveness of investigational new drugs. For example, under this prospective mechanism, persons with AIDS and HIV-related diseases who are not able to take standard therapy or for whom standard therapy is no longer effective, and who are not able to participate in ongoing controlled clinical trials, can have access to promising investigational new drugs. Applications to permit expanded availability of an investigational new drug under the Parallel Track mechanism must be submitted (typically by the manufacturer of the drug) to the FDA as an amendment to the existing IND.