REGULATORY STRATEGY FOR REGISTRATION OF COMBINATION PRODUCTS TO US-FDA

Abstract

In pharmaceutical industry all the healthcare products are categorized into Drugs, Devices, and biologics and they are regulated by their respective departments of the regulatory authorities. Due to more and more development of science and technology in the current scenario, had led to the invention of innovative novel products in healthcare system for better diagnosis and treatment of diseases, advancement of these novel technologies have led to a the blurring of historical lines of separation between the healthcare products, so these advances had led to the existence of combination products.
 Combination products raise a variety of regulatory and review challenges compared with single-entity products. They have the potential to provide enhanced therapeutic advantages. It ranges in complexity from Drug-eluting stents to gene therapy systems and from chemotherapeutic Drugs combined with monoclonal antibodies to novel nanotechnology-based Drug delivery systems. They include innovative products for diagnostic and therapeutic treatments of cardiovascular, metabolic, and oncologic disorders, among other types of products.
 In this article we describe the regulations for registration of combination products in US and their regulatory considerations for identification, jurisdiction and review, premarket activities, applicability of Good Manufacturing Practices (GMPs) and post marketed requirements, adverse event reporting, inspection and enforcement.