DNA vaccines have been termed as ‘The Third Generation of Vaccines’ due to their versatility and potential that can also be utilised to produce vaccines against some of the fatal and incurable diseases of today. The recent successful immunisation of experimental animals against a range of infectious agents and several tumour models of disease with plasmid DNA testifies to the powerful nature of this revolutionary approach in vaccinology. V.Balamuralidhara, Shilpi Khattri and their team at JSS College of Pharmacy explain the FDA evolution of policy, regulatory guidance, delivery mechanisms, safety issues, and document the pros and cons of DNA vaccines.