Investigational New Drug Submission
UAMS acts as the sponsor for all investigator-initiated INDs filed on behalf of our investigators (UAMS policy 12.1.10). The following are the functions and services of the Regulatory Affairs Staff:
- Regulatory Strategy – assist in helping investigators with all of regulatory needs throughout a series of investigations.
- FDA Interaction – conduct and coordinate all communication or correspondence with this government agency including submissions, teleconferences, and meetings.
- Regulatory Review – review clinical protocols to determine if an IND or IND exemption is needed.
- An IND will be needed if using a new chemical/biological entity, using a marketed drug in support of a different indication, or significantly increasing the risks associated with the use of the drug product (route of administration, dosage level, patient population, etc.) or manufacturing a marketed drug product entity.
- An IND exemption may be requested if the drug is lawfully marketed in the United States and meets all the following requirements: the investigation is not intended to be reported to the FDA as a well-controlled study in support of a new indication nor intended to change the labeling and the investigation does not involve a route of administration or dosage level or use in a patient population or other risk factor that significantly increases the risks or decreases the acceptability of the risks.
- IND – complete and submit the Investigational New Drug application (IND) to the FDA, coordinate FDA interactions, maintain sponsor records and inform investigators of their responsibilities.
- IND Exemption – complete and submit the Investigational New Drug Exemption (IND Exemption) to the FDA, coordinate FDA interactions, maintain sponsor records and inform investigators of their responsibilities.
- Filing and Maintenance – assist investigators in the preparation, filing, and maintenance of all applicable regulatory documents required for FDA submission.