UAMS acts as the sponsor for all investigator-initiated Investigational New Drug application (IND) 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.
- Food and Drug Administration 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 Investigational New Drug application or Investigational New Drug exemption is needed.
- An Investigational New Drug application 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 Investigational New Drug 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 Food and Drug Administration 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.
- Investigational New Drug application — complete and submit the Investigational New Drug application to the Food and Drug Administration, coordinate Food and Drug Administration interactions, maintain sponsor records and inform investigators of their responsibilities.
- Investigational New Drug Exemption — complete and submit the Investigational New Drug Exemption (IND Exemption) to the Food and Drug Administration, coordinate Food and Drug Administration 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 Food and Drug Administration submission.