Life Cycle Management of Investigational New Drug Application:

Life cycle management of IND applications involves activities that ensure compliance with the regulatory requirements and the safe & smooth running of clinical trials. The important things to consider during IND life cycle management are

1. Amendments
2. Annual Reports
3. Safety Reports

• Amendments – These are the necessary changes or updates made to the application and are divided into two types based on the type of change – Protocol amendments and information amendments
• Protocol Amendments: changes made in the protocol after submission like changes in the study design, eligibility criteria of the patients or change in the protocol. These have to be submitted to regulatory authority i.e. FDA before implementation.
• Information Amendments: if changes or updates do not fit into the scope of protocol amendments are kept under information amendments like providing data not there in the initial submission, like new changes of CMC information, adding on to the safety data, etc.

• Annual Reports:  These reports include information about the study progress, safety data, summary of changes etc. Annual reports must be submitted to FDA within 60 days of anniversary date
• Safety Reports:  These reports are to be submitted and based on severity the timelines vary.  serious ADRs should be submitted in 15 calendar days, fatal or life-threatening conditions should be reported in 7 calendar days and periodic updates on safety should be submitted such as every six months or based on stage of the clinical trails
• These are the key considerations of an IND application life cycle management.