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World Journal of Pharmacy and
Pharmaceutical Sciences

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical and Medical Research and Technology

Impact Factor : 8.485

ICV : 84.65

WJPPS Citation

	All	Since 2020
Citation	6651	4087
h-index	26	21
i10-index	174	83

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WJPPS Rank with Index Copernicus Value 84.65 due to high reputation at International Level

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WJPPS is indexed in Scope Database based on the recommendation of the Content Selection Committee (CSC).

WJPPS: New Impact Factor 2026

WJPPS Impact Factor has been Increased to 8.485 for Year 2026.

WJPPS: MAY ISSUE PUBLISHED

MAY 2026 Issue has been successfully launched on 1 MAY 2026.

Abstract

DRUG - DEVICE COMBINATION PRODUCTS: COMPARATIVE REGULATORY PATHWAYS IN THE UNITED STATES AND INDIA

Ketaki Umesh Shalgaonkar*, Prajakta Balakshe

ABSTRACT

A new dynamic in medical product development and regulatory approval was brought about by drug-device combo products. and business interactions that offer insightful insights for the creation of new combo product generations. With their promise for novel treatments, combination products which combine pharmaceuticals, biologics, and medical equipment have completely changed the healthcare industry. Every healthcare product in the pharmaceutical sector is divided into three categories: drugs, devices, and biologics. Each of these categories is governed by a different regulatory authority department. This article explores the complex world of safety, efficacy, and regulatory issues related to combination products.

Keywords: Regulatory approval, drug device.

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