Regulatory Prospective about Combination Products in USFDA

Main Article Content

Rajole Pratiksha R.
Sawant Prerana P.
Dhopare Mahesh R.
Kashid Girish A.


All healthcare goods in the pharmaceutical sector are classified as Drugs, Devices, and Biologics, and they are governed by their respective regulatory authorities. In the current context, Science and technological advancements have led to the development of innovative novel items in the healthcare sector. More accurate illness identification and treatment, as well as the growth of these revolutionary technologies, have resulted in a blurring of the lines. Due to historical distinctions between healthcare products, these developments gave rise to products with merged features. A regulation about combination products and the FDA's perspective. The article discusses guidelines regarding the combination product and what are the challenges that occur to regulate combination products

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How to Cite
Pratiksha R., R. ., Prerana P., S. ., Mahesh R., D. ., & Girish A. , K. . (2023). Regulatory Prospective about Combination Products in USFDA. Journal of Coastal Life Medicine, 11(1), 1533–1538. Retrieved from


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