Traditionally, drug development begins with the identification of an appropriate chemical or biologic molecule or compound.
After obtaining required regulatory approvals, clinical trial work may begin. Clinical trials are generally divided into formal “Phases” each with varying obligations and endpoints.
The regulatory requirements that govern the contents of an NDA are intended to give FDA enough information to make a meaningful evaluation of a drug.
All NDA applications must meet the basic substantive requirement that the drug is both “safe” and “effective”.
The approval of an NDA submission creates new obligations and responsibilities for the NDA holder.
The management of a drug life’s cycle begins with the identification of an appropriate chemical or biologic molecule or compound in the Pre-IND phase.