REGULATORY STRATEGY FOR REGISTRATION OF COMBINATION PRODUCTS TO US-FDA
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.
2. Lauritsen KJ, Nguyen T. Combination Products Regulation at the FDA. Clinical pharmacology & Therapeutics [Internet]. 2009 May[Cited 2014 Jun 11]. 85(5). Available from:
3. Mark D. Kramer Combination Products: Challenges and Progress. Regulatory Affairs Focus [Internet]. 2005 Aug [Cited 2014 May 1]. Available from:
4. Siew A, Navigating Landscape of Combination Products. Pharmaceutical Technology Europe [Internet]. 2014 April [Cited 2014 June 26]. Available from:
5. Huynh K B. Handbook of Stability Testing in Pharmaceutical Development. New York, NY 10013, USA: Springer Science Business Media; 2008.
6. Guidance for Industry and FDA Staff Early Development Considerations for Innovative Combination Products. Office of Combination Products (OCP). [Internet]. 2006 Sept [Cited 2014 June 3]. Available from:
7. Lewis A. Drug-Device Combination Products - Delivery Technologies and Applications. 1st edition. Wood head Publishing Limited and CRC Press LLC; 2010.
8. Suzanne O’Shea Working through the US Rules for Combination Products. The regulatory affairs journal. [Internet]. 2008 Oct [Cited 2014 May 5]. Available from:
9. Current Good Manufacturing Practice for Combination Products Guidance for Industry and FDA. Office of Combination Products (OCP). [Internet]. 2004 Sept [Cited 2014 May 7]. Available from:
10. Guidance for Industry and FDA Post marketing Safety Reporting for Combination Products. Office of Combination Products (OCP). [Internet]. 2009 Oct[Cited 2014 May 15]. Available from:
11. Burgunda V S, FASHP, Ann K S, and Dawn M P, Review of the Processes for FDA Oversight of Drugs, Medical Devices, and Combination Products. Journal of Managed Care Pharmacy. [Internet]. 2011 Jan [Cited 2014 June 24]. Available from:
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