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